VerSys®
229 catalogue numbers from 7843-21-06, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
229catalogue numbers in this listing
46510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K953337 |
| Record published | 2015-09-17 |
| Record revised | 2020-06-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7843-21-06 | 12/14 Neck Taper, Size 21, 21 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-12-18 | 12/14 Neck Taper, Size 12.0, 12.0 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7862-18-30 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7843-15-36 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-13-30 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7845-15-20 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 8018-32-01 | 12/14 Taper, 32 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 7862-17-30 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 65-7862-14-50 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7862-17 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 65-7862-17 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 7862-14-20 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7862-19-20 | 12/14 Neck Taper, Size 19, 155 mm Stem Length | In distribution |
| 7843-15-18 | 12/14 Neck Taper, Size 15.0, 15.0 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7843-13-81 | 12/14 Neck Taper, Size 13.5, 13.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7843-22-82 | 12/14 Neck Taper, Size 22.5, 22.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7843-17-26 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-12-50 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7862-19-30 | 12/14 Neck Taper, Size 19, 155 mm Stem Length | In distribution |
| 7843-13-18 | 12/14 Neck Taper, Size 13.5, 13.5 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7862-17-20 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 65-7862-20 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 7845-17-50 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-14 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7843-21-36 | 12/14 Neck Taper, Size 21, 21 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-15-20 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 8018-32-14 | 12/14 Taper, 32 mm Diameter, +7.0, mm, Neck Length | In distribution |
| 7841-14-20 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-13-50 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-12 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7845-15 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-18-26 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-15-08 | 12/14 Neck Taper, Size 15, 15 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7841-16-50 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-15-50 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-11-20 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 65-7862-15-50 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 7841-16-20 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-18 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-18 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-16 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-20-20 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-15-26 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-16-08 | 12/14 Neck Taper, Size 16, 16 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7841-20-20 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-13-20 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7841-16-30 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-14-30 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 65-7841-13 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-19-20 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-14-08 | 12/14 Neck Taper, Size 14, 14 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 65-7845-15 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-19-18 | 12/14 Neck Taper, Size 19.5, 19.5 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7862-11 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7843-19-06 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-19-82 | 12/14 Neck Taper, Size 19.5, 19.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7862-20-50 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 65-7862-17-50 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 8018-22-30 | 12/14 Taper, 22 mm Diameter, +3.0 mm, Neck Length | In distribution |
| 7841-12-30 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7845-13-30 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-15 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-16-30 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-17-50 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 7843-13-82 | 12/14 Neck Taper, Size 13.5, 13.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7843-13-26 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7841-16-30 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7841-10 | 12/14 Neck Taper, Size 10, 10 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7843-13-36 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-20-20 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 7841-20-30 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-22-26 | 12/14 Neck Taper, Size 22, 22 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-14-26 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-11 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7845-15-30 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-14-30 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 8018-28-01 | 12/14 Taper, 28 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 7862-16-20 | 12/14 Neck Taper, Size16, 145 mm Stem Length | In distribution |
| 65-7862-13 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7843-18-18 | 12/14 Neck Taper, Size 18.0, 18.0 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7862-16-50 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 7843-20-36 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-17 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-12-20 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 8018-36-03 | 12/14 Taper, 36 mm Diameter, +3.5, mm, Neck Length | In distribution |
| 7843-16-36 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-14-50 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7862-14 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7862-20 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 7841-15-20 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-18-30 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-20 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-16 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-15-50 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-12-20 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 8018-28-14 | 12/14 Taper, 28 mm Diameter, +7.0, mm, Neck Length | In distribution |
| 7845-17-30 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-20-26 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-17-06 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-12-20 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7841-18-50 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-15 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 7862-18 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 8018-40-04 | 12/14 Taper, 40 mm Diameter, +7.0, mm, Neck Length | In distribution |
| 7843-13-16 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 150 mm Stem Length | In distribution |
| 7845-19-20 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-18-36 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-13-30 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7843-16-81 | 12/14 Neck Taper, Size 16.5, 16.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7845-12-30 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 65-7862-12 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7841-14 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7862-14-30 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7843-12-26 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-20-30 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 7862-18-20 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7862-15-50 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 65-7862-11-50 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7862-09 | 12/14 Neck Taper, Size 9, 110 mm Stem Length | In distribution |
| 7862-15-30 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 7843-16-16 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 150 mm Stem Length | In distribution |
| 7843-13-08 | 12/14 Neck Taper, Size 13, 13 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7845-13 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-19 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-09 | 12/14 Neck Taper, Size 9, 9 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7843-16-26 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-10 | 12/14 Neck Taper, Size 10, 115 mm Stem Length | In distribution |
| 8018-40-05 | 12/14 Taper, 40 mm Diameter, +10.5, mm, Neck Length | In distribution |
| 7843-15-06 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-20-06 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-13 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 32-8018-26-05 | 12/14 Taper, 26 mm Diameter, +10.5, mm, Neck Length | In distribution |
| 7843-22-36 | 12/14 Neck Taper, Size 22, 22 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-12-50 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7841-17-30 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-20-46 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-14 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 32-8018-22-20 | 12/14 Taper, 22 mm Diameter, -2.0, mm, Neck Length | In distribution |
| 65-7845-17 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-19-46 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-11-20 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7843-14-16 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 150 mm Stem Length | In distribution |
| 7862-20-20 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 7845-20 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-13-50 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7841-09 | 12/14 Neck Taper, Size 9, 9 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7841-11-50 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7843-19-81 | 12/14 Neck Taper, Size 19.5, 19.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7843-20-08 | 12/14 Neck Taper, Size 20, 20 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7843-18-06 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 8018-26-01 | 12/14 Taper, 26 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 7862-19-50 | 12/14 Neck Taper, Size 19, 155 mm Stem Length | In distribution |
| 7843-22-81 | 12/14 Neck Taper, Size 22.5, 22.5 mm Distal Stem Diameter, 200 mm, Stem Length | In distribution |
| 7843-21-46 | 12/14 Neck Taper, Size 21, 21 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-11-36 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-18 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-18-30 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-11-50 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 65-7862-16-50 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 7841-13 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7843-22-18 | 12/14 Neck Taper, Size 22.5, 22.5 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7843-11-08 | 12/14 Neck Taper, Size 11, 11 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7843-14-06 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-12 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 65-7841-12 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 65-7841-15-30 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-12-30 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7843-18-46 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-19-36 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-15-16 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 150 mm Stem Length | In distribution |
| 7862-11-30 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 65-7862-18-50 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7843-18-08 | 12/14 Neck Taper, Size 18, 18 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 7841-14-30 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 65-7862-17-20 | 12/14 Neck Taper, Size 17, 150 mm Stem Length | In distribution |
| 7845-10 | 12/14 Neck Taper, Size 10, 10 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7862-18-50 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7845-12-20 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7862-15-20 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 7862-15 | 12/14 Neck Taper, Size 15, 140 mm Stem Length | In distribution |
| 8018-40-02 | 12/14 Taper, 40 mm Diameter, +0, mm, Length | In distribution |
| 8018-26-02 | 12/14 Taper, 26 mm Diameter, +0 mm, Neck Length | In distribution |
| 7843-12-56 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 8018-22-20 | 12/14 Taper, 22 mm Diameter, -2.0 mm, Neck Length | In distribution |
| 65-7862-11-20 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7841-11-30 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 7843-14-36 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-17-08 | 12/14 Neck Taper, Size 17, 17 mm Distal Diameter, 200 mm Stem Length | In distribution |
| 65-7862-14-30 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7841-10 | 12/14 Neck Taper, Size 10, 10 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 8018-36-02 | 12/14 Taper, 36 mm Diameter, +0, mm, Neck Length | In distribution |
| 7843-13-56 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-19-50 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-12 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7841-19-30 | 12/14 Neck Taper, Size 19, 19 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-20-30 | 12/14 Neck Taper, Size 20, 155 mm Stem Length | In distribution |
| 32-8018-28-02 | 12/14 Taper, 28 mm Diameter, +0, mm, Neck Length | In distribution |
| 7862-19 | 12/14 Neck Taper, Size 19, 155 mm Stem Length | In distribution |
| 7843-17-36 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-16-06 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-12-06 | 12/14 Neck Taper, Size 12, 12 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-20-50 | 12/14 Neck Taper, Size 20, 20 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-17 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-13-30 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7843-13-06 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7841-17-50 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-15-30 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7845-11 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
| 65-7862-11 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 65-7841-13-30 | 12/14 Neck Taper, Size 13, 13 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-14-50 | 12/14 Neck Taper, Size 14, 14 mm Distal Stem Diameter, 140 mm Stem Length | In distribution |
| 7841-15-30 | 12/14 Neck Taper, Size 15, 15 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7862-12-30 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7862-12-50 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7841-17-20 | 12/14 Neck Taper, Size 17, 17 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7845-16 | 12/14 Neck Taper, Size 16, 16 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 8018-36-04 | 12/14 Taper, 36 mm Diameter, +7.0, mm, Neck Length | In distribution |
| 7862-11-50 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7862-13-20 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7841-18-20 | 12/14 Neck Taper, Size 18, 18 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-21-18 | 12/14 Neck Taper, Size 21.0, 21.0 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7843-16-18 | 12/14 Neck Taper, Size 16.5, 16.5 mm Distal Stem Diameter, 190 mm, Stem Length | In distribution |
| 7862-16-30 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 7862-16 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 65-7862-18 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7843-22-06 | 12/14 Neck Taper, Size 22, 22 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 7843-22-56 | 12/14 Neck Taper, Size 22, 22 mm Distal Stem Diameter, 160 mm Stem Length | In distribution |
| 65-7862-14-20 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7845-11-30 | 12/14 Neck Taper, Size 11, 11 mm Distal Stem Diameter, 130 mm Stem Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252623 | 2026-02-04 |
| K211047 | 2023-01-10 |
| K190656 | 2019-12-06 |
| K190660 | 2019-12-05 |
| K183457 | 2019-11-05 |
| K182678 | 2019-05-31 |
| K151448 | 2015-08-13 |
| K123019 | 2012-10-22 |
| K113296 | 2012-09-14 |
| K103662 | 2011-04-15 |
| K101229 | 2010-12-03 |
| K093561 | 2010-04-28 |
| K091508 | 2009-09-11 |
| K061461 | 2006-12-20 |
| K061226 | 2006-08-02 |
| K061786 | 2006-07-24 |
| K060040 | 2006-05-12 |
| K052321 | 2006-02-15 |
| K051491 | 2005-06-30 |
| K042337 | 2004-11-04 |
| K042776 | 2004-11-04 |
| K041109 | 2004-07-20 |
| K033034 | 2003-11-05 |
| K032726 | 2003-10-22 |
| K031572 | 2003-06-24 |
| K030733 | 2003-05-01 |
| K030079 | 2003-02-05 |
| K021891 | 2002-09-05 |
| K014070 | 2002-07-30 |
| K003478 | 2001-02-05 |
| K002960 | 2000-12-11 |
| K994286 | 2000-03-10 |
| K992667 | 1999-10-27 |
| K990135 | 1999-07-12 |
| K980711 | 1998-11-12 |
| K973714 | 1997-12-24 |
| K964769 | 1997-02-13 |
| K953337 | 1996-01-22 |
| K954698 | 1996-01-17 |
| K953490 | 1995-10-20 |
| K934515 | 1995-03-07 |
| K934765 | 1994-04-29 |
| K922071 | 1994-02-22 |
| K921557 | 1994-02-22 |
| K921308 | 1994-02-22 |
| K921639 | 1992-07-02 |
Recalls Naming This Product
118 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2018-01-03 | Class II | Labeling mix-ups | Two lots of hip implants are mislabeled. | 24 | 2019-04-11 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2017-08-01 | Class II | Package design/selection | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. | 38,069 units total | 2020-03-18 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 1199 | 2017-07-05 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 130 | 2017-05-23 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 101 | 2017-05-23 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 1305 | 2017-05-23 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 4844 | 2017-05-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 209 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2236 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 512 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 17 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 3696 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2014-05-19 | Class II | Nonconforming Material/Component | During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively. | 147 units | 2015-03-24 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 6380 | 2014-09-25 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
Showing 40 of 118.
Recalls
25 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 72 units | |
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 63 units | |
| 2023-02-27 | Class II | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in fl | 1,168 untits | |
| 2020-08-14 | Class II | Under Investigation by firm | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. | 31 | 2022-06-09 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 294 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 138 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | 24 | 2020-05-28 | |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 665 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 101 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 510 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 96 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 84 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 182 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 1024 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 116 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 132 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 227 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 280 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 58 | 2020-05-28 |
| 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 24 | 2019-07-18 |
| 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 12 | 2019-07-18 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.