ZMR®
95 catalogue numbers from 9975-05-20, 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
95catalogue 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) | K113296 |
| Record published | 2016-07-18 |
| Record revised | 2024-09-11 (version 7) |
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 |
| Sizes | Length 83 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9975-05-20 | In distribution | |
| 9981-240-33 | 24.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9963-150-34 | Size 15.0, 260 mm Stem Length | In distribution |
| 9983-210-34 | 21.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9961-255-33 | Size 25.5, 220 mm Stem Length | In distribution |
| 9980-180-21 | 18.0 mm Diameter, 115 mm Stem Length | In distribution |
| 9922-22-13 | 22 mm Diameter, 135 mm Stem Length | In distribution |
| 9971-20-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 45 mm Build-Up | In distribution |
| 9922-20-13 | 20 mm Diameter, 135 mm Stem Length | In distribution |
| 9980-165-33 | 16.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9993-23-35 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 35 mm Build-Up | In distribution |
| 9993-20-35 | 12/14 Neck Taper, 46 mm Neck Offset, Size D, 35 mm Build-Up | In distribution |
| 9922-23-23 | 23 mm Diameter, 235 mm Stem Length | In distribution |
| 9990-20-46 | 12/14 Neck Taper, 46 mm Neck Offset, Size D, 35 mm Build-Up | In distribution |
| 9975-02-24 | Size 24.0 | In distribution |
| 9982-19-23 | 19 mm Diameter, 235 mm Stem Length | In distribution |
| 9961-165-21 | Size 16.5, 115 mm Stem Length | In distribution |
| 9970-18-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 35 mm Build-Up | In distribution |
| 9965-01-20 | In distribution | |
| 9982-20-18 | 20 mm Diameter, 185 mm Stem Length | In distribution |
| 9961-225-32 | Size 22.5, 170 mm Stem Length | In distribution |
| 9973-20-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 55 mm Build-Up | In distribution |
| 9990-19-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size C, 35 mm Build-Up | In distribution |
| 9974-19-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 55 mm Build-Up | In distribution |
| 9978-19-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 45 mm Build-Up | In distribution |
| 9921-240-32 | 24.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9982-16-18 | 16 mm Diameter, 185 mm Stem Length | In distribution |
| 9998-18-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 45 mm Build-Up | In distribution |
| 9978-17-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 35 mm Build-Up | In distribution |
| 9961-120-32 | Size 12.0, 170 mm Stem Length | In distribution |
| 9976-18-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9961-120-21 | Size 12.0, 115 mm Stem Length | In distribution |
| 9961-195-22 | Size 19.5, 170 mm Stem Length | In distribution |
| 9981-150-21 | 15.0 mm Diameter, 115 mm Stem Length | In distribution |
| 9921-240-33 | 24.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9971-18-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9922-19-18 | 19 mm Diameter, 185 mm Stem Length | In distribution |
| 9976-23-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size F 35 mm Build-Up | In distribution |
| 9955-20-10 | Size 20 | In distribution |
| 9923-83-45 | Length 83 mm | In distribution |
| 9962-16-18 | Size 16, 185 mm Stem Length | In distribution |
| 9980-240-33 | 24.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9975-03-21 | In distribution | |
| 00-9975-007-05 | In distribution | |
| 9952-18-23 | Size 18, 235 mm Stem Length | In distribution |
| 9980-195-32 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9962-19-23 | Size 19, 235 mm Stem Length | In distribution |
| 9982-19-18 | 19 mm Diameter, 185 mm Stem Length | In distribution |
| 9970-17-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 35 mm Build-Up | In distribution |
| 9977-17-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 45 mm Build-Up | In distribution |
| 9975-05-19 | In distribution | |
| 9922-20-23 | 20 mm Diameter, 235 mm Stem Length | In distribution |
| 9983-195-32 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9955-24-10 | Size 24 | In distribution |
| 9936-16-35 | 12/14 C-Ring Taper, 36 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9978-18-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 35 mm Build-Up | In distribution |
| 9978-17-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 55 mm Build-Up | In distribution |
| 9983-180-33 | 18.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9965-17-13 | Size 17 | In distribution |
| 9975-05-21 | In distribution | |
| 00-9996-046-55 | 46 mm Neck Offset, 55 mm Build-Up | In distribution |
| 9975-03-16 | AA/AA Minus (-) Body | In distribution |
| 9962-17-13 | Size 17, 135 mm Stem Length | In distribution |
| 9973-23-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 55 mm Build-Up | In distribution |
| 9961-255-32 | Size 25.5, 170 mm Stem Length | In distribution |
| 9973-19-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 55 mm Build-Up | In distribution |
| 9997-17-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9947-16-35 | 12/14 Neck Taper, 36 mm Neck Offset, Size AA Minus (-), 35 mm Build-Up | In distribution |
| 9975-01-16 | In distribution | |
| 9962-22-18 | Size 22, 185 mm Stem Length | In distribution |
| 00-9924-045-78 | 45 mm Neck Offset, 78 mm Build-Up | In distribution |
| 9977-18-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9980-195-21 | 19.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9965-01-17 | In distribution | |
| 9965-16-13 | Size 16 | In distribution |
| 9961-135-22 | Size 13.5, 170 mm Stem Length | In distribution |
| 9973-18-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 35 mm Build-Up | In distribution |
| 9961-240-33 | Size 24.0, 220 mm Stem Length | In distribution |
| 9975-01-23 | In distribution | |
| 9981-180-21 | 18.0 mm Diameter, 115 mm Stem Length | In distribution |
| 9990-23-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size F, 35 mm Build-Up | In distribution |
| 9990-17-46 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 35 mm Build-Up | In distribution |
| 9965-01-19 | In distribution | |
| 9993-17-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9970-21-46 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size E 35 mm Build-Up | In distribution |
| 9961-165-32 | Size 16.5, 170 mm Stem Length | In distribution |
| 9973-18-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9980-210-22 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9962-17-18 | Size 17, 185 mm Stem Length | In distribution |
| 9974-17-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 45 mm Build-Up | In distribution |
| 9965-73-02 | In distribution | |
| 9996-23-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size F, 35 mm Build-Up | In distribution |
| 9963-210-34 | Size 21.0, 260 mm Stem Length | In distribution |
| 9978-18-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9996-18-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 45 mm Build-Up | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| 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 |
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
15 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 | 2023-07-26 | 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 | |
| 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 | 2011-11-16 | Not classified | Nonconforming Material/Component | Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been inc | 1 unit (International Only Switzerland) | 2013-08-28 |
| Zimmer, Inc. | 510(k) number | 2011-11-16 | Not classified | Nonconforming Material/Component | Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been inc | 1 unit (Distributed to Demark) | 2013-08-28 |
| Zimmer, Inc. | 510(k) number | 2011-10-21 | Not classified | Error in labeling | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. | 119,284 total devices | 2013-08-29 |
| Zimmer, Inc. | 510(k) number | 2011-10-21 | Not classified | Error in labeling | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. | 119,284 total devices | 2013-08-29 |
| Zimmer, Inc. | 510(k) number | 2011-10-21 | Not classified | Error in labeling | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. | 119,284 total devices | 2013-08-29 |
| Zimmer, Inc. | 510(k) number | 2011-10-21 | Not classified | Error in labeling | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. | 119,284 total devices | 2013-08-29 |
| Zimmer, Inc. | 510(k) number | 2009-05-15 | Not classified | Process control | The threads on the screw are incomplete/non-functional. | 10 | 2009-11-12 |
| Zimmer, Inc. | 510(k) number | 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| Zimmer, Inc. | 510(k) number | 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| Zimmer, Inc. | 510(k) number | 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| Zimmer, Inc. | 510(k) number | 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| Zimmer, Inc. | 510(k) number | 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
Recalls
39 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) | |
| 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.