ZMR®
The ZMR Hip System is a modular system for cementless revision hip arthroplasty. The FDA filing names the ZMR Hip System and describes a femoral stem assembly with modular junctions between…
The ZMR Hip System is a modular system for cementless revision hip arthroplasty. The FDA filing names the ZMR Hip System and describes a femoral stem assembly with modular junctions between its components.
The filing states that the stems may be used for total hip and hemi-hip arthroplasty. It describes body and stem components intended to provide options for fixation and restoration of joint kinematics.
System Components
The filing describes the stem assembly as titanium alloy and says the system includes a femoral head taper connection. It identifies cementless revision hip arthroplasty as the system’s intended use.
14manufacturers in China registered for this device type
100catalogue numbers in this listing
46510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113296 |
| Record published | 2016-07-21 |
| Record revised | 2023-10-04 (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 |
|---|---|---|
| 9971-17-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 55 mm Build-Up | In distribution |
| 9981-210-33 | 21.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9921-255-32 | 25.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-210-22 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9963-225-34 | Size 22.5, 260 mm Stem Length | In distribution |
| 9976-19-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 55 mm Build-Up | In distribution |
| 9965-01-21 | In distribution | |
| 9976-20-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size D 35 mm Build-Up | In distribution |
| 9921-195-22 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9990-18-46 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 35 mm Build-Up | In distribution |
| 9994-17-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9965-19-13 | Size 19 | In distribution |
| 9981-195-21 | 19.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9922-23-18 | 23 mm Diameter, 185 mm Stem Length | In distribution |
| 9991-17-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9952-17-18 | Size 17, 185 mm Stem Length | In distribution |
| 9962-19-13 | Size 19, 135 mm Stem Length | In distribution |
| 9993-20-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size D, 45 mm Build-Up | In distribution |
| 9996-19-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size C, 55 mm Build-Up | In distribution |
| 9965-01-16 | In distribution | |
| 9980-195-22 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-195-32 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9952-23-18 | Size 23, 185 mm Stem Length | In distribution |
| 9996-16-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9952-01 | In distribution | |
| 9962-15-13 | Size 15, 135 mm Stem Length | In distribution |
| 9998-16-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9971-21-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size E 45 mm Build-Up | In distribution |
| 9970-18-46 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 35 mm Build-Up | In distribution |
| 9961-165-33 | Size 16.5, 220 mm Stem Length | In distribution |
| 9975-41 | 3/8 Inch Drive | In distribution |
| 9981-255-33 | 25.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9973-19-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 35 mm Build-Up | In distribution |
| 9974-20-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 55 mm Build-Up | In distribution |
| 00-9996-036-30 | 36 mm Neck Offset, Size AA Minus (-) Build-Up | In distribution |
| 9993-17-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 55 mm Build-Up | In distribution |
| 9981-195-33 | 19.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9970-19-46 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 35 mm Build-Up | In distribution |
| 9977-19-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 45 mm Build-Up | In distribution |
| 9953-83-45 | 12/14 C-Ring Taper, 45 mm Neck Offset | In distribution |
| 9975-02-12 | Size 12.0 | In distribution |
| 9921-240-34 | 24.0 mm Diameter, 260 mm Stem Length | In distribution |
| 00-9996-040-45 | 40 mm Neck Offset, 45 mm Build-Up | In distribution |
| 9921-195-33 | 19.5 mm Diameter, 220 mm Stem Length | In distribution |
| 00-9996-046-35 | 46 mm Neck Offset, 35 mm Build-Up | In distribution |
| 9994-20-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size D, 55 mm Build-Up | In distribution |
| 9991-21-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 45 mm Build-Up | In distribution |
| 9965-02-19 | Size 19.5 | In distribution |
| 9974-18-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 55 mm Build-Up | In distribution |
| 9974-21-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size E 55 mm Build-Up | In distribution |
| 9991-18-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 45 mm Build-Up | In distribution |
| 9996-18-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 9983-180-34 | 18.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9952-17-13 | Size 17, 135 mm Stem Length | In distribution |
| 9938-16-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size AA Minus (-) 35 mm Build-Up | In distribution |
| 9990-19-46 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 35 mm Build-Up | In distribution |
| 9980-135-22 | 13.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9970-16-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9921-255-33 | 25.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9980-150-33 | 15.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9997-17-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 55 mm Build-Up | In distribution |
| 9975-05-16 | In distribution | |
| 9981-150-22 | 15.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9994-21-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 55 mm Build-Up | In distribution |
| 00-9975-007-02 | XL Body | In distribution |
| 9983-210-32 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9952-18-13 | Size 18, 135 mm Stem Length | In distribution |
| 9975-02-22 | Size 22.5 | In distribution |
| 9980-150-32 | 15.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9965-42 | In distribution | |
| 9923-83-40 | 12/14 Neck Taper, 40 mm Neck Offset | In distribution |
| 00-9996-040-30 | 40 mm Neck Offset, Size AA Minus (-) Build-Up | In distribution |
| 9973-17-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 45 mm Build-Up | In distribution |
| 9961-150-22 | Size 15.0, 170 mm Stem Length | In distribution |
| 9921-165-34 | 16.5 mm Diameter, 260 mm Stem Length | In distribution |
| 9998-18-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 9962-15-18 | Size 15, 185 mm Stem Length | In distribution |
| 9965-18-13 | Size 18 | In distribution |
| 9990-16-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9993-18-35 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 35 mm Build-Up | In distribution |
| 9922-24-23 | 24 mm Diameter, 235 mm Stem Length | In distribution |
| 9975-36-10 | In distribution | |
| 9974-23-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 55 mm Build-Up | In distribution |
| 9993-19-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 45 mm Build-Up | In distribution |
| 9970-23-46 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 35 mm Build-Up | In distribution |
| 9962-18-13 | Size 18, 135 mm Stem Length | In distribution |
| 9982-15-13 | 15 mm Diameter, 135 mm Stem Length | In distribution |
| 00-9924-040-13 | 40 mm Neck Offset, 103 mm Build-Up | In distribution |
| 9961-180-21 | Size 18.0, 115 mm Stem Length | In distribution |
| 9981-135-21 | 13.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9981-240-22 | 24.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9980-255-33 | 25.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9975-02-13 | Size 13.5 | In distribution |
| 9981-225-22 | 22.5 mm Diameter, 170 mm Stem Length | In distribution |
| 00-9924-045-83 | 45 mm Neck Offset, 83 mm Build-Up | In distribution |
| 9975-02-25 | Size 25.5 | In distribution |
| 00-9975-007-18 | B Body | In distribution |
| 9980-150-22 | 15.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9965-22-18 | Size 22 | In distribution |
| 9994-23-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 55 mm Build-Up | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252623 | 2026-02-04 |
| K211047 | 2023-01-10 |
| K190656 | 2019-12-06 |
| K190660 | 2019-12-05 |
| K183457 | 2019-11-05 |
| K182678 | 2019-05-31 |
| K151448 | 2015-08-13 |
| K123019 | 2012-10-22 |
| K113296 | 2012-09-14 |
| K103662 | 2011-04-15 |
| K101229 | 2010-12-03 |
| K093561 | 2010-04-28 |
| K091508 | 2009-09-11 |
| K061461 | 2006-12-20 |
| K061226 | 2006-08-02 |
| K061786 | 2006-07-24 |
| K060040 | 2006-05-12 |
| K052321 | 2006-02-15 |
| K051491 | 2005-06-30 |
| K042337 | 2004-11-04 |
| K042776 | 2004-11-04 |
| K041109 | 2004-07-20 |
| K033034 | 2003-11-05 |
| K032726 | 2003-10-22 |
| K031572 | 2003-06-24 |
| K030733 | 2003-05-01 |
| K030079 | 2003-02-05 |
| K021891 | 2002-09-05 |
| K014070 | 2002-07-30 |
| K003478 | 2001-02-05 |
| K002960 | 2000-12-11 |
| K994286 | 2000-03-10 |
| K992667 | 1999-10-27 |
| K990135 | 1999-07-12 |
| K980711 | 1998-11-12 |
| K973714 | 1997-12-24 |
| K964769 | 1997-02-13 |
| K953337 | 1996-01-22 |
| K954698 | 1996-01-17 |
| K953490 | 1995-10-20 |
| K934515 | 1995-03-07 |
| K934765 | 1994-04-29 |
| K922071 | 1994-02-22 |
| K921557 | 1994-02-22 |
| K921308 | 1994-02-22 |
| K921639 | 1992-07-02 |
Recalls Naming This Product
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
38 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 72 units | |
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 63 units | |
| 2023-02-27 | Class II | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in fl | 1,168 untits | |
| 2020-08-14 | Class II | Under Investigation by firm | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. | 31 | 2022-06-09 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 294 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 138 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | 24 | 2020-05-28 | |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 665 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 101 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 510 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 96 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 84 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 182 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 1024 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 116 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 132 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 227 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 280 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 58 | 2020-05-28 |
| 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 24 | 2019-07-18 |
| 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 12 | 2019-07-18 |
| 2018-01-03 | Class II | Labeling mix-ups | Two lots of hip implants are mislabeled. | 24 | 2019-04-11 |
| 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 |
| 2017-11-29 | 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 |
| 2017-08-01 | 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 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.