VerSys®
The VerSys Cemented Revision/Calcar Hip System includes femoral stems and build-up blocks for total hip arthroplasty. The filing describes the stems as permanent implants supplied sterile…
The VerSys Cemented Revision/Calcar Hip System includes femoral stems and build-up blocks for total hip arthroplasty. The filing describes the stems as permanent implants supplied sterile by gamma irradiation.
The source describes use in reconstructive hip procedures for deficiencies of the femoral head, neck or proximal femur. The stems and build-up blocks use specified cobalt-chromium-molybdenum and titanium alloys.
Implant Components
The system includes femoral stems with a taper for the corresponding femoral head, plus build-up blocks and associated screws. The filing identifies the components as permanent hip implants.
13manufacturers in China registered for this device type
74catalogue 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) | K210842 |
| Record published | 2015-09-17 |
| Record revised | 2022-01-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 10 to 30 mm; outer diameter 9 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7871-01-20 | Height 20 mm | In distribution |
| 8018-28-05 | 12/14 Taper, 28 mm Diameter, +10.5 mm, Neck Length | In distribution |
| 7858-16-57 | Size 16 | In distribution |
| 7818-50 | 12/14 Taper, 50 mm Diameter | In distribution |
| 8018-28-03 | 12/14 Taper, 28 mm Diameter, +3.5 mm, Neck Length | In distribution |
| 32-8018-26-03 | 12/14 Taper, 26 mm Diameter, +3.5, mm, Neck Length | In distribution |
| 32-8018-28-04 | 12/14 Taper, 28 mm Diameter, +7 mm Neck Length | In distribution |
| 7818-57 | 12/14 Taper, 57 mm Diameter | In distribution |
| 7859-12 | Outer Diameter 12 mm | In distribution |
| 7858-25-57 | Size 15 | In distribution |
| 32-8018-28-01 | 12/14 Taper, 28 mm Diameter, -3.5, mm, Neck Length | In distribution |
| 7818-99 | 12/14 Taper, +7.0 mm Neck Length | In distribution |
| 7871-01-30 | Height 30 mm | In distribution |
| 7858-26-57 | Size 16 | In distribution |
| 7858-13-57 | Size 13 | In distribution |
| 7871-13-62 | 12/14 Neck Taper, Size 13, 250 mm Stem Length | In distribution |
| 7871-15-61 | 12/14 Neck Taper, Size 15, 220 mm Stem Length | In distribution |
| 7871-15-62 | 12/14 Neck Taper, Size 15, 250 mm Stem Length | In distribution |
| 7833-12 | 12/14 Neck Taper, Size 12, 125 mm Stem Length | In distribution |
| 7859-09 | Outer Diameter 9 mm | In distribution |
| 7871-13-63 | 12/14 Neck Taper, Size 13, 300 mm Stem Length | In distribution |
| 32-8018-28-03 | 12/14 Taper, 28 mm Diameter, +3.5 mm Neck Length | In distribution |
| 7818-99-01 | 12/14 Taper, +10.5 mm Neck Length | In distribution |
| 8018-40-03 | 12/14 Taper, 40 mm Diameter, +3.5, mm, Neck Length | In distribution |
| 7859-17 | Outer Diameter 17 mm | In distribution |
| 32-8018-26-02 | 12/14 Taper, 26 mm Diameter, +0, mm, Neck Length | In distribution |
| 7858-17-57 | Size 17 | In distribution |
| 7833-14 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7871-13-61 | 12/14 Neck Taper, Size 13, 210 mm Stem Length | In distribution |
| 7858-23-57 | Size 13 | In distribution |
| 7871-01-10 | Height 10 mm | In distribution |
| 8018-28-02 | 12/14 Taper, 28 mm Diameter, +0 mm, Neck Length | In distribution |
| 7818-55 | 12/14 Taper, 55 mm Diameter | In distribution |
| 8018-36-01 | 12/14 Taper, 36 mm Diameter, -3.5, mm, Neck Length | In distribution |
| 7858-24-57 | Size 14 | In distribution |
| 8018-22-02 | 12/14 Taper, 22 mm Diameter, +0 mm, Neck Length | In distribution |
| 7871-17-60 | 12/14 Neck Taper, Size 17, 190 mm Stem Length | In distribution |
| 7818-49 | 12/14 Taper, 49 mm Diameter | In distribution |
| 7833-16 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 8018-32-05 | 12/14 Taper, 32 mm Diameter, +10.5 mm, Neck Length | In distribution |
| 7833-13 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7871-02-30 | Size 17/19 | In distribution |
| 8018-32-02 | 12/14 Taper, 32 mm Diameter, +0 mm, Neck Length | In distribution |
| 8018-32-03 | 12/14 Taper, 32 mm Diameter, +3.5 mm, Neck Length | In distribution |
| 8018-26-05 | 12/14 Taper, 26 mm Diameter, +10.5 mm, Neck Length | In distribution |
| 7871-15-60 | 12/14 Neck Taper, Size 15, 180 mm Stem Length | In distribution |
| 7834-13 | 12/14 Neck Taper, Size 13, 130 mm Stem Length | In distribution |
| 7834-14 | 12/14 Neck Taper, Size 14, 135 mm Stem Length | In distribution |
| 7871-17-61 | 12/14 Neck Taper, Size 17, 230 mm Stem Length | In distribution |
| 7859-18 | Outer Diameter 18 mm | In distribution |
| 7858-11-57 | Size 11 | In distribution |
| 8018-36-05 | 12/14 Taper, 36 mm Diameter, +10.5, mm, Neck Length | In distribution |
| 7871-02-10 | Height 10 mm | In distribution |
| 7871-19-60 | 12/14 Neck Taper, Size 19, 200 mm Stem Length | In distribution |
| 7858-15-57 | Size 15 | In distribution |
| 32-8018-22-30 | 12/14 Taper, 22 mm Diameter, +3.0, mm, Neck Length | In distribution |
| 7871-15-63 | 12/14 Neck Taper, Size 15, 300 mm Stem Length | In distribution |
| 7818-63 | 12/14 Taper, 63 mm Diameter | In distribution |
| 7833-18 | 12/14 Neck Taper, Size 18, 155 mm Stem Length | In distribution |
| 7871-02-20 | Height 20 mm | In distribution |
| 8018-40-01 | 12/14 Taper, 40 mm Diameter, -3.5, mm, Neck Length | In distribution |
| 7834-16 | 12/14 Neck Taper, Size 16, 145 mm Stem Length | In distribution |
| 7834-10 | 12/14 Neck Taper, Size 10, 115 mm Stem Length | In distribution |
| 7859-14 | Outer Diameter 14 mm | In distribution |
| 7859-19 | Outer Diameter 19 mm | In distribution |
| 7858-12-57 | Size 12 | In distribution |
| 8018-26-04 | 12/14 Taper, 26 mm Diameter, +7 mm, Neck Length | In distribution |
| 7834-11 | 12/14 Neck Taper, Size 11, 120 mm Stem Length | In distribution |
| 7818-48 | 12/14 Taper, 48 mm Diameter | In distribution |
| 7858-14-57 | Size 14 | In distribution |
| 7818-46 | 12/14 Taper, 46 mm Diameter | In distribution |
| 7818-99-02 | 12/14 Taper, +14.0 mm Neck Length | In distribution |
| 7871-13-60 | 12/14 Neck Taper, Size 13, 170 mm Stem Length | In distribution |
| 8018-26-03 | 12/14 Taper, 26 mm Diameter, +3.5 mm, Neck Length | 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
105 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 | 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. | 2,239 | 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. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2236 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 512 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 17 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 3696 | 2017-04-13 |
| Zimmer 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. | 5013 | 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. | 1220 | 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 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. | 360 | 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. | 2388 | 2017-04-13 |
| 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 | 2013-12-10 | Class II | Labeling mix-ups | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and | 36 | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-12-10 | Class II | Labeling mix-ups | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and | 3 | 2014-09-11 |
| 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 | 2013-10-11 | 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 | 2013-08-28 | Class II | Packaging process control | Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility me | 12866 units | 2015-04-30 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
Showing 40 of 105.
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.