NexGen®
679 catalogue numbers from 5989-04-26, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
679catalogue numbers in this listing
51510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K152494 |
| Record published | 2016-09-27 |
| Record revised | 2023-04-04 (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 |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Height 5 to 23 mm; length 3.5 to 200 mm |
| Distribution end date | 2017-04-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5989-04-26 | Size 4, 5 mm Thickness | In distribution | |
| 5950-57-01 | Size 7 | In distribution | |
| 90-5970-30-14 | Size Yellow / C-H | In distribution | |
| 5976-31-10 | Size Striped Yellow/A-E | In distribution | |
| 5997-28-02 | Size 2 | In distribution | |
| 5970-18-01 | Size H | In distribution | |
| 5990-36-22 | Size F, 10 mm Augment | In distribution | |
| SSI004650 | Height 10 mm | In distribution | |
| 5989-05-36 | Size 5, 5 mm Thickness | In distribution | |
| 5990-36-21 | Size F, 10 mm Augment | In distribution | |
| 5996-28-01 | Size 1 | In distribution | |
| 5989-03-36 | Size 3, 5 mm Thickness | In distribution | |
| 90-5970-50-20 | Size Blue / C-H, With Locking Screw | In distribution | |
| 5990-35-22 | Size E, 10 mm Augment | In distribution | |
| SSI004644 | Height 5 mm | In distribution | |
| 5988-01-27 | Size 1, 10 mm, Thickness | In distribution | |
| 5988-20-16 | Length 100 mm | In distribution | |
| 90-5970-20-14 | Size Purple/A-E | In distribution | |
| 5989-33-31 | Size C | In distribution | |
| 5990-35-24 | Size E, 20 mm Augment | In distribution | |
| 5989-07-29 | Size 7, 20 mm Thickness | In distribution | |
| 5989-06-23 | Size 6, 7 Degrees | In distribution | |
| 5970-45-01 | Size 5 | In distribution | |
| 5988-10-10 | 10 mm Dia, (Combined Length 145 mm) | In distribution | |
| 32-5988-12-13 | 13 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 90-5970-21-12 | Size Striped Purple / C-H | In distribution | |
| 5966-04-10 | Size 4 | In distribution | |
| 5989-02-37 | Size 2, 10 mm Thickness | In distribution | |
| 5988-12-15 | 15 mm Diameter, (Combined Length 75 mm) | In distribution | |
| 5976-50-12 | Size Blue | In distribution | |
| 5988-10-16 | 16 mm Dia, (Combined Length 145 mm) | In distribution | |
| 5970-14-02 | Size D | In distribution | |
| 5988-15-22 | 22 mm Dia, (Combined Length 120 mm) | In distribution | |
| 5950-16-06 | Size F Minus, (F-) | In distribution | |
| 90-5970-50-12 | Height 12.00 mm | In distribution | |
| 90-5970-31-20 | Height 20.00 mm | In distribution | |
| 5952-16-06 | Size F Minus, (F-) | In distribution | |
| 5990-33-02 | Size C, 10 mm Augment | In distribution | |
| 5988-21-16 | 16 mm Diameter, (Combined Length 200 mm) | In distribution | |
| 5966-03-10 | Size 3 | In distribution | |
| 5988-15-14 | 14 mm Dia, (Combined Length 120 mm) | In distribution | |
| 5988-16-12 | Length 130 mm | In distribution | |
| 90-5970-21-09 | Height 9 mm | In distribution | |
| 5976-31-23 | Height 23.00 mm | In distribution | |
| 5989-06-28 | Size 6, 15 mm Thickness | In distribution | |
| 5976-40-17 | Height 17 mm | In distribution | |
| 5989-06-39 | Size 6, 20 mm Thickness | In distribution | |
| 5976-21-10 | Height 10 mm | In distribution | |
| 5988-10-14 | 14 mm Dia, (Combined Length 145 mm) | In distribution | |
| 5990-36-24 | Size F, 20 mm Augment | In distribution | |
| 5976-41-23 | Height 23.00 mm | In distribution | |
| 5988-19-13 | 13 mm Diameter, (Combined Length 145 mm) | In distribution | |
| 5972-65-29 | Size 29, mm Diameter, 8.0 mm Thickness | In distribution | |
| 5988-16-19 | 19 mm Dia, (Combined Length 175 mm) | In distribution | |
| 5988-20-18 | Length 100 mm | In distribution | |
| 5980-47-02 | Size 6 | In distribution | |
| 5966-06-12 | Size 6 | In distribution | |
| 5980-37-12 | Size 4+ | In distribution | |
| 5988-10-24 | 24 mm Dia, (Combined Length 145 mm) | In distribution | |
| 5989-09-33 | Size 9, 7 Degrees | In distribution | |
| 5989-05-21 | Size 5, 26 Degrees | In distribution | |
| 5976-30-10 | Height 10.00 mm | In distribution | |
| 5989-08-28 | Size 8, 15 mm Thickness | In distribution | |
| 5976-21-14 | Height 14 mm | In distribution | |
| 5956-15-02 | Size E | In distribution | |
| 5989-02-30 | Height 8.6 mm | In distribution | |
| 5989-08-31 | Height 18.5 mm | In distribution | |
| 5990-34-31 | Size D | In distribution | |
| 32-5988-12-16 | 16 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 5988-03 | Size 3 | In distribution | |
| 5950-14-05 | Size D Minus, (D-) | In distribution | |
| 5980-57-03 | Size 9 | In distribution | |
| 5989-03-32 | Size 3, 22 Degrees | In distribution | |
| 00-5955-016-91 | Size F | In distribution | |
| 90-5970-31-17 | Size Striped Yellow/A-E | In distribution | |
| 5970-45-02 | Size 6 | In distribution | |
| 5966-16-02 | Size F | In distribution | |
| 5976-30-20 | Size Yellow | In distribution | |
| 00-5901-046-00 | Size F | In distribution | |
| 90-5970-21-14 | Height 14 mm | In distribution | |
| 5989-08-36 | Size 8, 5 mm Thickness | In distribution | |
| 5989-09-23 | Height 11 mm | In distribution | |
| 5976-41-12 | Height 12.00 mm | In distribution | |
| 5989-02-31 | Height 14 mm | In distribution | |
| 5988-15-18 | Length 75 mm | In distribution | |
| 5988-01-28 | Size 1, 15 mm, Thickness | In distribution | |
| 5976-21-12 | Size Striped Purple | In distribution | |
| 90-5970-31-20 | Height 20.00 mm | In distribution | |
| 5989-01-27 | Size 1, 10 mm Thickness | In distribution | |
| 5970-18-02 | Size H | In distribution | |
| 5976-50-23 | Size Blue | In distribution | |
| 5996-58-02 | Size 8 | In distribution | |
| 5988-02-38 | Size 2, 15 mm, Thickness | In distribution | |
| 5988-02-29 | Size 2, 20 mm, Thickness | In distribution | |
| 5989-05-30 | Size 5, 16 Degrees | In distribution | |
| 5990-33-24 | Size C, 20 mm Augment | In distribution | |
| 5989-02-36 | Size 2, 5 mm Thickness | In distribution | |
| 5976-40-23 | Size Green | In distribution | |
| 90-5970-20-10 | Height 10.00 mm | In distribution | |
| 90-5970-21-10 | Height 10 mm | In distribution | |
| 90-5970-50-20 | Height 20.00 mm | In distribution | |
| 5989-07-28 | Size 7, 15 mm Thickness | In distribution | |
| 90-5970-20-14 | Size Purple/A-E | In distribution | |
| 90-5970-40-20 | Size Green / C-H | In distribution | |
| 5996-58-03 | Size 9 | In distribution | |
| 5989-03-30 | Height 9.5 mm | In distribution | |
| 5990-37-22 | Size G, 10 mm Augment | In distribution | |
| 5988-10-20 | 20 mm Dia, (Combined Length 145 mm) | In distribution | |
| 90-5970-50-14 | Size Blue / C-H | In distribution | |
| 5988-08-38 | Size 8, 15 mm, Thickness | In distribution | |
| 5881-16-01 | Size F | In distribution | |
| 00-5901-040-00 | In distribution | ||
| 5966-06-10 | Size 6 | In distribution | |
| 5990-37-21 | Size G, 10 mm Augment | In distribution | |
| 5989-07-33 | Size 7, 7 Degrees | In distribution | |
| 32-5988-12-14 | 14 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 5956-13-06 | Size C Minus, (C-) | In distribution | |
| 5881-14-01 | Size D | In distribution | |
| 5956-15-05 | Size E Minus, (E-) | In distribution | |
| 5989-04-33 | Height 8 mm | In distribution | |
| 5970-21-12 | Height 12 mm | In distribution | |
| 5988-02-28 | Size 2, 15 mm, Thickness | In distribution | |
| 5989-05-23 | Size 5, 7 Degrees | In distribution | |
| 5996-48-02 | Size 6 | In distribution | |
| 5988-16-17 | 17 mm Dia, (Combined Length 175 mm) | In distribution | |
| 5990-36-23 | Size F, 15 mm Augment | In distribution | |
| 90-5970-30-10 | Size Yellow / C-H | In distribution | |
| 5989-07-39 | Size 7, 20 mm Thickness | In distribution | |
| 5970-17-02 | Size G | In distribution | |
| 5989-06-33 | Height 9 mm | In distribution | |
| 5952-14-02 | Size D | In distribution | |
| 5966-14-01 | Size D | In distribution | |
| 5988-05-39 | Size 5, 20 mm, Thickness | In distribution | |
| 90-5970-31-14 | Height 14.00 mm | In distribution | |
| 5972-65-38 | Size 38, mm Diameter, 9.5 mm Thickness | In distribution | |
| 5881-15-02 | Size E | In distribution | |
| 5950-15-01 | Size E | In distribution | |
| 90-5970-50-14 | Height 14.00 mm | In distribution | |
| 5986-57-02 | Size 8 | In distribution | |
| 5956-17-02 | Size G | In distribution | |
| 5990-37-24 | Size G, 20 mm Augment | In distribution | |
| 5988-01-38 | Size 1, 15 mm, Thickness | In distribution | |
| 5989-07-30 | Height 11.5 mm | In distribution | |
| 5966-05-12 | Size 5 | In distribution | |
| 5988-16-10 | 10 mm Dia, (Combined Length 175 mm) | In distribution | |
| 5950-13-05 | Size C Minus, (C-) | In distribution | |
| 5990-37-02 | Size G, 10 mm Augment | In distribution | |
| 00-5955-014-92 | Size D | In distribution | |
| 5989-06-37 | Size 6, 10 mm Thickness | In distribution | |
| 5988-01-29 | Size 1, 20 mm, Thickness | In distribution | |
| 5988-16-11 | 11 mm Dia, (Combined Length 175 mm) | In distribution | |
| 5988-01-10 | Size 1, 10 mm, Thickness | In distribution | |
| 5970-14-01 | Size D | In distribution | |
| 5966-03-17 | Size 3 | In distribution | |
| 32-5988-12-20 | 20 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 5989-04-23 | Height 8 mm | In distribution | |
| 5988-21-17 | Length 155 mm | In distribution | |
| 5950-15-05 | Size E Minus, (E-) | In distribution | |
| 5960-99 | In distribution | ||
| 5972-65-29 | Size 29, mm Diameter, 8.0 mm Thickness | In distribution | |
| 5976-50-20 | Size Blue | In distribution | |
| 5980-57-04 | Size 10 | In distribution | |
| 5988-03-27 | Size 3, 10 mm Thickness | In distribution | |
| 5966-07-14 | Size 7 | In distribution | |
| 5988-16-24 | 24 mm Dia, (Combined Length 175 mm) | In distribution | |
| SSI004636 | Height 5 mm | In distribution | |
| 5970-55-01 | Size 7 | In distribution | |
| 5989-01-29 | Size 1, 20 mm Thickness | In distribution | |
| 32-5988-12-22 | 22 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 90-5970-40-14 | Height 14.00 mm | In distribution | |
| 5990-34-20 | Size D, 10 mm Augment | In distribution | |
| 5988-09-23 | Size 9, 7 Degrees | In distribution | |
| 90-5970-40-20 | Size Green / C-H | In distribution | |
| 5966-07-17 | Size 7 | In distribution | |
| 5990-35-23 | Size E, 15 mm Augment | In distribution | |
| 5988-16-15 | 15 mm Dia, (Combined Length 175 mm) | In distribution | |
| 5989-04-36 | Size 4, 5 mm Thickness | In distribution | |
| 5988-07-29 | Size 7, 20 mm, Thickness | In distribution | |
| 5988-07-23 | Size 7, 7 Degrees | In distribution | |
| 5996-58-04 | Size 10 | In distribution | |
| 90-5970-40-12 | Size Green / C-H | In distribution | |
| 90-5970-30-09 | Height 9.00 mm | In distribution | |
| 5988-10-22 | 22 mm Dia, (Combined Length 145 mm) | In distribution | |
| 5988-03-26 | Size 3, 5 mm Thickness | In distribution | |
| 5988-02-22 | Size 2, 22 Degrees | In distribution | |
| 5990-35-01 | Size E, 5 mm Augment | In distribution | |
| 5990-34-01 | Size D, 5 mm Augment | In distribution | |
| 5989-08-37 | Size 8, 10 mm Thickness | In distribution | |
| 5989-02-10 | Size 2, 10 mm Thickness | In distribution | |
| 5988-11-16 | 16 mm Diameter, (Combined Length 200 mm) | In distribution | |
| 5956-15-06 | Size E Minus, (E-) | In distribution | |
| 90-5970-50-17 | Size Blue / C-H, With Locking Screw | In distribution | |
| 5989-07-20 | Size 7, 16 Degrees | In distribution | |
| 5989-08-32 | Height 10.5 mm | In distribution | |
| 5990-33-23 | Size C, 15 mm Augment | In distribution | |
| 5989-06-31 | Size 6, 26 Degrees | In distribution | |
| 90-5970-31-17 | Height 17.00 mm | In distribution | |
| 5988-07-10 | Size 7, 10 mm, Thickness | In distribution | |
| 5966-05-14 | Size 5 | In distribution | |
| 5970-16-01 | Size F | In distribution | |
| 5988-15-16 | 16 mm Dia, (Combined Length 120 mm) | In distribution | |
| 5990-36-02 | Size F, 10 mm Augment | In distribution | |
| 32-5988-12-18 | 18 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 5956-16-01 | Size F | In distribution | |
| 5989-07-32 | Height 10.5 mm | In distribution | |
| 5988-03-20 | Size 3, 16 Degrees | In distribution | |
| 90-5970-40-14 | Height 14 mm | In distribution | |
| 5989-03-27 | Size 3, 10 mm Thickness | In distribution | |
| 5990-35-02 | Size E, 10 mm Augment | In distribution | |
| 5988-91 | 2 | In distribution | |
| 90-5970-21-12 | Size Striped Purple / C-H | In distribution | |
| 5970-40-12 | Size Green | In distribution | |
| 5950-15-06 | Size E Minus, (E-) | In distribution | |
| 5966-04-14 | Size 4 | In distribution | |
| 5988-04-21 | Size 4, 26 Degrees | In distribution | |
| 5988-20-14 | Length 100 mm | In distribution | |
| 5990-35-24 | Size E, 20 mm Augment | In distribution | |
| 5989-06-30 | Height 10.5 mm | In distribution | |
| 5988-20-12 | 12 mm Diameter, (Combined Length 145 mm) | In distribution | |
| 5989-05-26 | Size 5, 5 mm Thickness | In distribution | |
| 5950-15-02 | Size E | In distribution | |
| 5976-21-12 | Height 12 mm | In distribution | |
| 90-5970-20-20 | Size Purple/A-E | In distribution | |
| 5988-21-18 | Length 155 mm | In distribution | |
| 32-5988-12-15 | 15 mm Diameter, (Combined Length 245 mm) | In distribution | |
| 5988-04-28 | Size 4, 15 mm, Thickness | In distribution | |
| 5976-30-12 | Size Yellow | In distribution | |
| 5880-04-10 | Size 4, 10 mm, Thickness | In distribution | |
| 00-5960-090-10 | In distribution | ||
| 5988-10-15 | 15 mm Dia, (Combined Length 145 mm) | In distribution | |
| 5950-67 | In distribution | ||
| 5988-15-13 | 13 mm Dia, (Combined Length 120 mm) | In distribution | |
| 5987-30 | 7 Degree | In distribution | |
| 5956-12-02 | Size B | In distribution | |
| SSI004658 | Height 10 mm | In distribution | |
| 5976-50-23 | Size Blue | In distribution | |
| 5976-50-14 | Height 14.00 mm | In distribution | |
| 5988-90 | Length 3.5 mm | In distribution | |
| 5976-40-10 | Height 10.00 mm | In distribution | |
| 5990-35-31 | Size E | In distribution | |
| 5970-50-10 | Height 10 mm | In distribution | |
| 5950-37-12 | Size 4+ | In distribution | |
| 5976-31-14 | Size Striped Yellow/A-E | In distribution | |
| 00-5901-048-00 | Size H | In distribution | |
| 5988-05-22 | Size 5, 22 Degrees | In distribution | |
| 5990-34-24 | Size D, 20 mm Augment | In distribution | |
| 5988-01-39 | Size 1, 20 mm, Thickness | In distribution | |
| 5976-41-17 | Height 17.00 mm | In distribution | |
| 00-5901-043-00 | Size C | In distribution | |
| 5966-06-14 | Size 6 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243724 | 2025-03-06 |
| K230321 | 2023-03-08 |
| K221479 | 2022-11-17 |
| K210829 | 2021-05-18 |
| K210551 | 2021-03-18 |
| K200209 | 2020-03-24 |
| K193223 | 2020-01-24 |
| K191625 | 2019-09-05 |
| K190068 | 2019-06-04 |
| K183583 | 2019-05-10 |
| K181947 | 2018-10-25 |
| K173057 | 2018-03-29 |
| K152494 | 2015-11-25 |
| K142787 | 2014-12-22 |
| K133737 | 2014-02-04 |
| K130143 | 2013-02-22 |
| K122765 | 2012-11-09 |
| K113369 | 2012-03-27 |
| K073286 | 2008-03-07 |
| K072281 | 2007-09-06 |
| K062768 | 2006-10-13 |
| K061882 | 2006-08-01 |
| K060722 | 2006-05-26 |
| K060370 | 2006-04-28 |
| K052879 | 2005-11-22 |
| K050723 | 2005-04-20 |
| K043101 | 2005-03-07 |
| K042271 | 2004-10-13 |
| K023211 | 2002-10-17 |
| K013991 | 2001-12-27 |
| K003910 | 2001-03-19 |
| K991581 | 1999-07-30 |
| K972774 | 1999-05-05 |
| K972270 | 1997-11-24 |
| K963148 | 1997-02-13 |
| K962196 | 1996-08-23 |
| K960279 | 1996-04-26 |
| K951185 | 1996-03-15 |
| K946150 | 1995-07-11 |
| K933785 | 1995-01-30 |
| K930831 | 1993-11-16 |
| K911572 | 1991-07-01 |
| K895639 | 1990-02-08 |
| K892800 | 1989-08-03 |
| K872379 | 1987-10-28 |
| K863805 | 1986-12-02 |
| K853661 | 1985-12-09 |
| K834432 | 1984-04-11 |
| K833363 | 1984-02-13 |
| K830121 | 1983-04-26 |
| K790219 | 1979-05-08 |
Recalls Naming This Product
139 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 | 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| Zimmer, Inc. | 510(k) number | 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| Zimmer, Inc. | 510(k) number | 2024-03-28 | Class II | Process change control | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | 5,546 units | |
| Zimmer, Inc. | 510(k) number | 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1673 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2092 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2460 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1366 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1049 | |
| Zimmer, Inc. | 510(k) number | 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 284 | |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2018-10-31 | Class II | Process control | Screw is missing from the package | 19 units | 2019-04-08 |
| 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. | 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 | 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr | 24 | 2018-07-03 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 42064 | 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. | 117359 | 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. | 88389 | 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. | 32508 | 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. | 49 | 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. | 53338 | 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. | 29525 | 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. | 202221 | 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. | 1767 | 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. | 39 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2015-12-03 | Class II | Labeling mix-ups | A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. | 384 distribution events; 1 unit was returned leaving 383 uni | 2016-09-15 |
| Zimmer Manufacturing B.V. | 510(k) number | 2015-12-02 | Class II | Packaging | Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 | 179 | 2016-09-16 |
| Zimmer, Inc. | 510(k) number | 2015-04-02 | Class II | Mixed-up of materials/components | The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery | 20 units | 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 | 2013-10-31 | Class II | Device Design | Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose | 128 units | 2015-04-30 |
Showing 40 of 139.
Recalls
15 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 |
|---|---|---|---|---|---|
| 2025-02-27 | Class II | Labeling Change Control | The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the translations section of the same label. | 76 units | |
| 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 |
| 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 |
| 2017-11-29 | 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 |
| 2017-11-29 | 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 |
| 2017-11-29 | 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 |
| 2017-11-29 | 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 |
| 2017-11-29 | 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 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 61485 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18093 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 84396 | 2017-05-23 |
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.