Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
836 catalogue numbers from 2347-08-10, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
836catalogue numbers in this listing
27510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K150121 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 32 |
| Sizes | Length 6 to 423 mm; lumen/inner diameter 22 to 60 mm; outer diameter 4.5 to 81 mm; length 1 to 24 in; length 60 cm |
| Distribution end date | 2018-10-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2347-08-10 | 10 Holes | In distribution | |
| 47-1162-25 | 4.7 mm, Diameter | In distribution | |
| 32-9026-49 | 6 Degree Taper, 26 mm Diameter, 7 mm Neck Length | In distribution | |
| 4927-07-18 | Length 45 mm | In distribution | |
| 47-2480-028-40 | Length 28 mm | In distribution | |
| 2348-09-06 | 6 Holes | In distribution | |
| 4935-33-04 | Length 50 mm | In distribution | |
| 9364-28-069 | Size 28mm/69mm | In distribution | |
| 4364-32-069 | Outer Diameter 69 mm | In distribution | |
| 2348-25-06 | Length 96 mm | In distribution | |
| 7351-30-015 | Diameter, 15 mm | In distribution | |
| 4927-08-03 | 8 Holes | In distribution | |
| 2347-03-04 | 3.5 mm Proximal Lateral Tibial Plate, 4 Holes | In distribution | |
| 2348-03-08 | 4.5 mm Proximal Lateral Humeral Plate, 8 Holes | In distribution | |
| 2348-09-10 | 10 Holes | In distribution | |
| 187-01-59 | Length 9 in | 6 | In distribution |
| 804-01-10 | Length 3 in | In distribution | |
| 2348-05-08 | 8 Holes | In distribution | |
| 1109-15 | 15 mm | In distribution | |
| 32-9026-49-35 | 6 Degree Taper, 26 mm Diameter, +10.5 mm Neck Length | In distribution | |
| 2347-04-06 | 3.5 mm Proximal Lateral Tibial Plate, 6 Holes | In distribution | |
| 4820-08-01 | 2.0 mm Cortical Screw | In distribution | |
| 4945-04-12 | 4.5 mm L-Buttress Plate, 4 Holes | In distribution | |
| 2347-01-08 | Length 178 mm | In distribution | |
| 2348-02-04 | 3.5 mm Proximal Lateral Humeral Plate, 4 Holes | In distribution | |
| 2347-04-04 | Length 59 mm | In distribution | |
| 4945-13 | Length 215 mm | In distribution | |
| 2347-17-16 | Length 198 mm | In distribution | |
| 1179-06-24 | 3.5 mm Recon Bone Plate – Curved, 24 Holes | In distribution | |
| 8011-30-01 | 28 Millimeter Diameter Flange, 14 Millimeter Diameter Core, 32 Millimeter Diameter Flange, 16 Millimeter Diameter Core | In distribution | |
| 47-2480-030-40 | Length 30 mm | In distribution | |
| 4915-20-02 | Length 100 mm | In distribution | |
| 4365-22-049 | Outer Diameter 49 mm | In distribution | |
| 4935-33-05 | 3.5 mm T-Plate Oblique, 3 Hole-Head, 3 Hole-Shaft | In distribution | |
| 4935-14 | 3.5 mm Compression Plate, 14 Holes | In distribution | |
| 47-1162-24 | 4.7 mm, Diameter, 1 3/4 Inch, Length | In distribution | |
| 2347-31-06 | Length 137 mm | In distribution | |
| 4820-14-01 | 2.0 mm Cortical Screw | In distribution | |
| 4920-03-02 | 2.0 mm Straight Plate, 3 Holes | In distribution | |
| 7351-30-011 | Diameter, 11 mm | In distribution | |
| 4366-28-073 | Outer Diameter 73 mm | In distribution | |
| 8005-01 | Outer Diameter 52.00 mm | In distribution | |
| 47-1162-19 | 4.7 mm, Diameter, 1/2 Inch, Length | In distribution | |
| 4927-07 | 2.7 mm Compression Plate, 7 Holes | In distribution | |
| 4945-20 | Length 326 mm | In distribution | |
| 2347-13-08 | 4.5 mm Proximal Medial Tibial Plate, 8 Holes | In distribution | |
| 4945-08-14 | Length 170 mm | In distribution | |
| 8011-20-16 | 16 mm Diameter Flange, 8 mm Diameter Core | In distribution | |
| 4927-03-09 | 2.7 mm L-Plate Oblique | In distribution | |
| 4364-22-043 | Outer Diameter 43 mm | In distribution | |
| 47-1162-22 | 4.7 mm, Diameter, 1 1/4 Inch, Length | In distribution | |
| 803-28 | In distribution | ||
| 2347-05-12 | 4.5 mm Proximal Lateral Tibial Plate, 12 Holes | In distribution | |
| 47-2480-018-40 | 4.0 mm, Diameter | In distribution | |
| 4366-32-079 | Outer Diameter 79 mm | In distribution | |
| 4820-46-03 | Length 46 mm | In distribution | |
| 4364-32-055 | Lumen/Inner Diameter 32 mm | In distribution | |
| 2347-06-12 | 4.5 mm Proximal Lateral Tibial Plate, 12 Holes | In distribution | |
| 2348-13-08 | 8 Holes | In distribution | |
| 2348-25-04 | Length 75 mm | In distribution | |
| 2348-13-06 | 6 Holes | In distribution | |
| 4935-10-16 | 3.5 mm Cloverleaf Plate, 10 Holes | In distribution | |
| 4945-07 | Length 119 mm | In distribution | |
| 4820-46-01 | Length 46 mm | In distribution | |
| 4815-14-01 | Length 14 mm | In distribution | |
| 4827-44-01 | Length 44 mm | In distribution | |
| 9026-36-10 | 6 Degree Taper, 36 mm Diameter, 10.5 mm Neck Length | In distribution | |
| 47-2480-034-41 | 4.0 mm, Diameter | In distribution | |
| 2347-10-14 | 14 Holes | In distribution | |
| 2347-32-08 | Length 169 mm | In distribution | |
| 2348-14-04 | Length 54 mm | In distribution | |
| 4820-12-01 | 2.0 mm Cortical Screw | In distribution | |
| 2347-08-12 | 12 Holes | In distribution | |
| 4900-20-51 | Outer Diameter 4.5 mm | In distribution | |
| 1179-07-04 | 4.5 mm Straight Recon Plate, 4 Holes | In distribution | |
| 4920-04-20 | 2.0 mm H-Plate, 4 Holes | In distribution | |
| 803-01-05 | 1/8 Inch, Diameter, 5-1/2 Inch, Length | In distribution | |
| 4920-02-19 | Length 39 mm | In distribution | |
| 2348-21-02 | Length 34 mm | In distribution | |
| 4820-06-03 | 2.0 mm Cortical Screw | In distribution | |
| 2347-10-10 | Length 133 mm | In distribution | |
| 802-01-17 | 3/16 Inch, Diameter, 18 1/2 Inch, Length | In distribution | |
| 9363-26-065 | Size 26mm/65mm | In distribution | |
| 186-03-69 | Length 9 in | 6 | In distribution |
| 4920-10 | Length 52 mm | In distribution | |
| 2348-07-16 | Length 111 mm | In distribution | |
| 4366-28-077 | Outer Diameter 77 mm | In distribution | |
| 4927-06-03 | Length 47 mm | In distribution | |
| 47-2480-040-41 | Length 40 mm | In distribution | |
| 1179-06-22 | 3.5 mm Recon Bone Plate – Curved, 22 Holes | In distribution | |
| 4815-10-03 | 1.5 mm Cortical Screw | In distribution | |
| 4820-10-03 | Length 10 mm | In distribution | |
| 47-1162-20 | 4.7 mm, Diameter, 3/4 Inch, Length | In distribution | |
| 2347-12-04 | 3.5 mm Proximal Medial Tibial Plate, 4 Holes | In distribution | |
| 803-01-11 | 1/8 Inch, Diameter, 8-1/2 Inch, Length | In distribution | |
| 4945-06 | Length 103 mm | In distribution | |
| 7351-30-013 | Diameter, 13 mm | In distribution | |
| 5000-05-005 | In distribution | ||
| 2347-03-16 | Length 202 mm | In distribution | |
| 2348-18-05 | Length 64 mm | In distribution | |
| 2347-17-04 | Length 73 mm | In distribution | |
| 47-2480-012-40 | Length 12 mm | In distribution | |
| 4820-36-01 | 2.0 mm Cortical Screw | In distribution | |
| 4935-12 | Length 145 mm | In distribution | |
| 2347-03-14 | Length 178 mm | In distribution | |
| 00-5851-030-38 | 38 mm Offset | In distribution | |
| 4365-32-081 | Outer Diameter 81 mm | In distribution | |
| 4364-28-049 | Lumen/Inner Diameter 28 mm | In distribution | |
| 802-01-02 | 3/16 Inch, Diameter | In distribution | |
| 4827-58-01 | 2.7 mm Cortical Screw | In distribution | |
| 8005-48 | Outer Diameter 52 mm | In distribution | |
| 4945-20-01 | 4.5 mm Compression Plate-Broad, 20 Holes | In distribution | |
| 2347-05-14 | 4.5 mm Proximal Lateral Tibial Plate, 14 Holes | In distribution | |
| 187-04-59 | Length 9 in | 6 | In distribution |
| 186-27-12 | Length 6 in | 6 | In distribution |
| 4945-18-01 | 4.5 mm Compression Plate-Broad, 18 Holes | In distribution | |
| 9362-22-041 | Size 22 mm/41 mm | In distribution | |
| 1179-07-15 | 4.5 mm Straight Recon Plate, 15 Holes | In distribution | |
| 4827-48-01 | Length 48 mm | In distribution | |
| 2348-14-02 | 2 Holes | In distribution | |
| 4945-08-01 | Length 135 mm | In distribution | |
| 2348-22-04 | 4 Holes | In distribution | |
| 803-01-07 | 1/8 Inch, Diameter, 6-1/2 Inch, Length | In distribution | |
| 9026-33-35 | 6 Degree Taper, 32 mm Diameter, 10.5 mm Neck Length | In distribution | |
| 2347-10-16 | 16 Holes | In distribution | |
| 4820-44-03 | Length 44 mm | In distribution | |
| 2347-09-04 | Length 61 mm | In distribution | |
| 806-01-11 | 3/32 Inch, Diameter, 8-1/2 Inch, Length | In distribution | |
| 4815-18-01 | Length 18 mm | In distribution | |
| 2348-13-12 | Length 137 mm | In distribution | |
| 2348-09-04 | 4 Holes | In distribution | |
| 32-9026-58 | 6 Degree Taper, 22 mm Diameter, +11.0 mm Neck Length | In distribution | |
| 6732-95 | Lumen/Inner Diameter 32 mm | In distribution | |
| 47-2480-032-41 | 4.0 mm, Diameter | In distribution | |
| 2347-07-16 | 16 Holes | In distribution | |
| 1179-13-22 | 2.7 mm Straight Recon Plate, 22 Holes | In distribution | |
| 1179-07-03 | 4.5 mm Straight Recon Plate, 3 Holes | In distribution | |
| 2348-25-02 | 2 Holes | In distribution | |
| 4820-20-01 | Length 20 mm | In distribution | |
| 262-06-04 | Length 9 in | 6 | In distribution |
| 4935-07-03 | Length 85 mm | In distribution | |
| 9026-36 | 6 Degree Taper, 36 mm Diameter, 0 mm Neck Length | In distribution | |
| 9026-34 | 6 Degree Taper, 32 mm Diameter, 14 mm Neck Length | In distribution | |
| 9363-32-079 | Size 32mm/79mm | In distribution | |
| 9363-28-047 | Size 28mm/47mm | In distribution | |
| 4935-07-16 | 3.5 mm Cloverleaf Plate, 7 Holes | In distribution | |
| 32-9026-40 | 6 Degree Taper, 28 mm Diameter, 0 mm Neck Length | In distribution | |
| 2347-01-10 | Length 210 mm | In distribution | |
| 4945-22 | Length 358 mm | In distribution | |
| 4364-32-057 | Lumen/Inner Diameter 32 mm | In distribution | |
| 4815-09-01 | 1.5 mm Cortical Screw | In distribution | |
| 2347-15-04 | 4 Holes | In distribution | |
| 2347-18-10 | 10 Holes | In distribution | |
| 9362-44-071 | Size 44mm/71mm | In distribution | |
| 4365-28-059 | Lumen/Inner Diameter 28 mm | In distribution | |
| 4915-02-19 | 1.5 mm Condylar Plate | In distribution | |
| 1179-06-20 | 3.5 mm Recon Bone Plate – Curved, 20 Holes | In distribution | |
| 2347-15-02 | Length 51 mm | In distribution | |
| 4827-56-01 | Length 56 mm | In distribution | |
| 4945-24 | Length 390 mm | In distribution | |
| 2347-17-12 | 12 Holes | In distribution | |
| 2347-15-06 | Length 95 mm | In distribution | |
| 4927-08 | Length 68 mm | In distribution | |
| 2347-07-18 | 18 Holes | In distribution | |
| 9026-22-45 | 6 Degree Taper, 22 mm Diameter, +7.0 mm Neck Length | In distribution | |
| 2348-10-08 | 8 Holes | In distribution | |
| 2348-04-12 | Length 235 mm | In distribution | |
| 4945-09-14 | Length 186 mm | In distribution | |
| 2347-07-10 | Length 168 mm | In distribution | |
| 2348-09-12 | Length 152 mm | In distribution | |
| 4366-28-081 | Outer Diameter 81 mm | In distribution | |
| 4935-22 | 3.5 mm Compression Plate, 22 Holes | In distribution | |
| 4900-65-51 | Outer Diameter 13 mm | In distribution | |
| 2347-15-20 | Length 241 mm | In distribution | |
| 2348-26-08 | 8 Holes | In distribution | |
| 2348-26-06 | 6 Holes | In distribution | |
| 1179-07-16 | 4.5 mm Straight Recon Plate, 16 Holes | In distribution | |
| 47-2480-040-40 | Length 40 mm | In distribution | |
| 4820-28-03 | Length 28 mm | In distribution | |
| 4927-05-03 | Length 39 mm | In distribution | |
| 804-01-09 | 3/32 Inch, Diameter, 2-3/4 Inch, Length | In distribution | |
| 4935-10 | 3.5 mm Compression Plate, 10 Holes | In distribution | |
| 2347-32-04 | 4 Holes | In distribution | |
| 47-2480-032-40 | 4.0 mm, Diameter | In distribution | |
| 2348-01-04 | Length 92 mm | In distribution | |
| 4915-01-19 | Length 37 mm | In distribution | |
| 4935-46-04 | Length 78 mm | In distribution | |
| 9363-32-053 | Size 32mm/53mm | In distribution | |
| 47-2480-030-41 | 4.0 mm, Diameter | In distribution | |
| 4935-05-03 | 5 Holes | In distribution | |
| 2348-04-04 | Length 107 mm | In distribution | |
| 2348-02-02 | 3.5 mm Proximal Lateral Humeral Plate, 2 Holes | In distribution | |
| 4815-06-03 | 1.5 mm Cortical Screw | In distribution | |
| 2347-18-08 | Length 115 mm | In distribution | |
| 2348-07-12 | Length 79 mm | In distribution | |
| 4364-22-045 | Lumen/Inner Diameter 22 mm | In distribution | |
| 2347-06-06 | Length 105 mm | In distribution | |
| 2348-01-14 | Length 212 mm | In distribution | |
| 802-01-05 | 3/16 Inch, Diameter, 10-1/4 Inch, Length | In distribution | |
| 2347-15-08 | Length 116 mm | In distribution | |
| 1179-05-18 | 3.5 mm Recon Bone Plate – Straight, 18 Holes | In distribution | |
| 4935-16 | Length 194 mm | In distribution | |
| 4920-08 | Length 42 mm | In distribution | |
| 2348-05-10 | Length 132 mm | In distribution | |
| 4815-24-03 | Length 24 mm | In distribution | |
| 4945-10-14 | Length 202 mm | In distribution | |
| 2348-02-16 | 3.5 mm Proximal Lateral Humeral Plate, 16 Holes | In distribution | |
| 2347-09-12 | 12 Holes | In distribution | |
| 802-01-07 | 3/16 Inch, Diameter, 11-3/4 Inch, Length | In distribution | |
| 186-02-69 | Length 9 in | 6 | In distribution |
| 2348-06-10 | 10 Holes | In distribution | |
| 4820-30-03 | 2.0 mm Cortical Screw | In distribution | |
| 2348-06-08 | 8 Holes | In distribution | |
| 2347-16-16 | 16 Holes | In distribution | |
| 47-4900-065-51 | Outer Diameter 13 mm | In distribution | |
| 4364-32-073 | Lumen/Inner Diameter 32 mm | In distribution | |
| 4945-08-03 | Length 135 mm | In distribution | |
| 2347-17-10 | 10 Holes | In distribution | |
| 806-01-08 | Length 7 in | In distribution | |
| 2348-18-07 | Length 85 mm | In distribution | |
| 2347-08-14 | Length 216 mm | In distribution | |
| 6722-83 | Lumen/Inner Diameter 22 mm | In distribution | |
| 4364-32-063 | Outer Diameter 63 mm | In distribution | |
| 4927-05 | 2.7 mm Compression Plate, 5 Holes | In distribution | |
| 4935-02 | Length 25 mm | In distribution | |
| 9666-38-800 | 12/14 Taper Trial Head, 38 mm, +8.0 mm Neck | In distribution | |
| 4365-26-061 | Lumen/Inner Diameter 26 mm | In distribution | |
| 4820-20-03 | Length 20 mm | In distribution | |
| 4820-40-03 | 2.0 mm Cortical Screw | In distribution | |
| 4815-22-03 | Length 22 mm | In distribution | |
| 4945-05-03 | 5 Holes | In distribution | |
| 4820-30-01 | 2.0 mm Cortical Screw | In distribution | |
| 2348-13-10 | Length 116 mm | In distribution | |
| 4945-12-03 | Length 199 mm | In distribution | |
| 8005-02 | Outer Diameter 52.00 mm | In distribution | |
| 4365-32-055 | Outer Diameter 55 mm | In distribution | |
| 4935-20 | Length 242 mm | In distribution | |
| 4820-26-03 | Length 26 mm | In distribution | |
| 2347-02-16 | 16 Holes | In distribution | |
| 2348-17-02 | Length 33 mm | In distribution | |
| 801-01-02 | Length 11 in | In distribution | |
| 4927-09 | 2.7 mm Compression Plate, 9 Holes | In distribution | |
| 2347-05-04 | 4.5 mm Proximal Lateral Tibial Plate, 4 Holes | In distribution | |
| 2348-02-10 | 3.5 mm Proximal Lateral Humeral Plate, 10 Holes | In distribution | |
| 4935-06-16 | 3.5 mm Cloverleaf Plate, 6 Holes | In distribution | |
| 4920-01-19 | Length 39 mm | In distribution | |
| 2348-17-03 | Length 44 mm | In distribution | |
| 4820-12-03 | 2.0 mm Cortical Screw | In distribution | |
| 4365-28-077 | Outer Diameter 77 mm | In distribution | |
| 4365-22-047 | Outer Diameter 47 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 98 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210842 | 2021-12-10 |
| K191449 | 2020-07-16 |
| K200823 | 2020-07-09 |
| K191735 | 2020-03-20 |
| K051516 | 2005-07-27 |
| K050105 | 2005-05-17 |
| K030153 | 2003-04-01 |
| K030265 | 2003-03-04 |
| K001733 | 2000-06-20 |
| K963109 | 1997-01-09 |
| K960278 | 1996-07-25 |
| K960658 | 1996-07-16 |
| K955473 | 1996-02-16 |
| K954744 | 1996-01-23 |
| K950312 | 1995-05-17 |
| K944792 | 1995-04-26 |
| K913649 | 1991-11-13 |
| K902436 | 1990-08-29 |
| K901364 | 1990-05-18 |
| K874229 | 1987-11-03 |
| K842906 | 1984-08-24 |
| K840643 | 1984-04-17 |
| K833912 | 1983-12-22 |
| K821893 | 1982-09-14 |
| K812182 | 1981-08-18 |
| K811293 | 1981-06-24 |
| K770908 | 1977-05-23 |
Recalls Naming This Product
37 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 | 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 | |
| Zimmer, Inc. | 510(k) number | 2018-03-29 | Class II | Under Investigation by firm | There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process. | 1,145 distribution events. Note that this product is lot con | 2019-12-17 |
| 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. | 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. | 366 | 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. | 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. | 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. | 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. | 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. | 4353 | 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. | 13 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2015-02-05 | Class II | Process control | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. | 1 unit | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 1908 | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-07-22 | Class II | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations faile | 972,125 units | 2015-09-15 |
| 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 | 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 1000 | 2014-04-16 |
| Zimmer, Inc. | 510(k) number | 2010-07-05 | Not classified | Other | Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect. | 103 | 2011-01-12 |
| Zimmer, Inc. | 510(k) number | 2010-07-05 | Not classified | Other | Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect. | 103 | 2011-01-12 |
| Zimmer, Inc. | 510(k) number | 2009-08-03 | Not classified | Manufacturing material removal | Manufacturing material may be present on the surface of the implant. | 104 | 2009-12-15 |
| Zimmer, Inc. | 510(k) number | 2009-06-08 | Not classified | Packaging process control | The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility. | 133 | 2009-12-15 |
| Zimmer, Inc. | 510(k) number | 2005-04-15 | Not classified | Other | May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm. | 38 | 2005-08-11 |
| Centerpulse Orthopedics, Inc. | 510(k) number | 2003-09-30 | Not classified | Other | Compalints of acetabular shell disassociating with the bone. | 145 units | 2004-11-04 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2024-07-02 | Class II | Under Investigation by firm | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. | 5,500 (US); 242,000 (OUS) | |
| 2023-07-26 | Class II | Mixed-up of materials/components | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. | 24 units | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
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.