ZMR®
129 catalogue numbers from 9961-195-32, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
129catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113296 |
| Record published | 2016-07-21 |
| Record revised | 2020-06-02 (version 6) |
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 78 to 103 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9961-195-32 | Size 19.5, 170 mm Stem Length | In distribution |
| 9998-19-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size C, 55 mm Build-Up | In distribution |
| 9921-240-22 | 24.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9974-18-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9981-255-22 | 25.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9980-255-32 | 25.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9980-135-21 | 13.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9965-02-16 | Size 16.5 | In distribution |
| 9963-240-34 | Size 24.0, 260 mm Stem Length | In distribution |
| 9923-93-40 | 12/14 Neck Taper, 40 mm Neck Offset | In distribution |
| 9976-16-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9952-18-18 | Size 18, 185 mm Stem Length | In distribution |
| 9923-103-45 | 12/14 Neck Taper, 45 mm Neck Offset | In distribution |
| 9952-22-23 | Size 22, 235 mm Stem Length | In distribution |
| 9952-21-18 | Size 21, 185 mm Stem Length | In distribution |
| 9998-17-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 55 mm Build-Up | In distribution |
| 9981-135-33 | 13.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9980-150-21 | 15.0 mm Diameter, 115 mm Stem Length | In distribution |
| 9921-180-32 | 18.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9980-165-22 | 16.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-225-34 | 22.5 mm Diameter, 260 mm Stem Length | In distribution |
| 00-9975-007-01 | In distribution | |
| 9990-21-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size E, 35 mm Build-Up | In distribution |
| 9981-225-33 | 22.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9961-180-32 | Size 18.0, 170 mm Stem Length | In distribution |
| 9942-16-35 | 12/14 Neck Taper, 36 mm Neck Offset, Size AA Minus (-), 35 mm Build-Up | In distribution |
| 9921-210-33 | 21.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9922-19-13 | 19 mm Diameter, 135 mm Stem Length | In distribution |
| 9946-16-35 | 12/14 Neck Taper, 36 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9975-01-17 | In distribution | |
| 9963-255-34 | Size 25.5, 260 mm Stem Length | In distribution |
| 9921-165-32 | 16.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9982-22-18 | 22 mm Diameter, 185 mm Stem Length | In distribution |
| 9993-19-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 55 mm Build-Up | In distribution |
| 9955-22-10 | Size 22 | In distribution |
| 9982-17-18 | 17 mm Diameter, 185 mm Stem Length | In distribution |
| 00-9975-007-21 | E Body | In distribution |
| 9981-210-32 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9961-210-32 | Size 21.0, 170 mm Stem Length | In distribution |
| 9921-165-22 | 16.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9983-150-33 | 15.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9953-78-45 | 12/14 C-Ring Taper, 45 mm Neck Offset | In distribution |
| 9981-120-32 | 12.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9975-05-23 | In distribution | |
| 9980-135-32 | 13.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9978-19-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 55 mm Build-Up | In distribution |
| 9996-17-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9983-240-32 | 24.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9993-21-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 45 mm Build-Up | In distribution |
| 9965-02-18 | Size 18.0 | In distribution |
| 9998-17-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 45 mm Build-Up | In distribution |
| 9937-16-35 | 12/14 C-Ring Taper, 36 mm Neck Offset, Size AA Minus (-) 35 mm Build-Up | In distribution |
| 9922-21-18 | 21 mm Diameter, 185 mm Stem Length | In distribution |
| 9981-120-22 | 12.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9993-18-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 9991-21-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 55 mm Build-Up | In distribution |
| 9983-195-33 | 19.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9981-165-32 | 16.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9980-165-21 | 16.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9921-255-22 | 25.5 mm Diameter, 170 mm Stem Length | In distribution |
| 00-9996-046-45 | 46 mm Neck Offset, 45 mm Build-Up | In distribution |
| 9982-18-23 | 18 mm Diameter, 235 mm Stem Length | In distribution |
| 9952-19-18 | Size 19, 185 mm Stem Length | In distribution |
| 9983-255-33 | 25.5 mm Diameter, 220 mm Stem Length | In distribution |
| 00-9975-007-00 | In distribution | |
| 9998-17-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 35 mm Build-Up | In distribution |
| 9973-23-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 35 mm Build-Up | In distribution |
| 9961-150-33 | Size 15.0, 220 mm Stem Length | In distribution |
| 00-9924-040-83 | 40 mm Neck Offset, 83 mm Build-Up | In distribution |
| 9923-78-40 | Length 78 mm | In distribution |
| 00-9996-040-55 | 40 mm Neck Offset, 55 mm Build-Up | In distribution |
| 9952-24-18 | Size 24, 185 mm Stem Length | In distribution |
| 9961-210-33 | Size 21.0, 220 mm Stem Length | In distribution |
| 9922-22-23 | 22 mm Diameter, 235 mm Stem Length | In distribution |
| 9976-18-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 35 mm Build-Up | In distribution |
| 9965-01-23 | In distribution | |
| 9993-21-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 55 mm Build-Up | In distribution |
| 9961-135-21 | Size 13.5, 115 mm Stem Length | In distribution |
| 9991-18-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 00-9975-007-20 | D Body | In distribution |
| 9955-23-10 | Size 23 | In distribution |
| 9953-83-40 | Length 83 mm | In distribution |
| 9978-18-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9970-21-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size E 35 mm Build-Up | In distribution |
| 9996-17-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 35 mm Build-Up | In distribution |
| 9932-16-35 | 12/14 C-Ring Taper, 36 mm Neck Offset, Size AA Minus (-) 35 mm Build-Up | In distribution |
| 9993-18-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 45 mm Build-Up | In distribution |
| 9952-19-13 | Size 19, 135 mm Stem Length | In distribution |
| 9990-20-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size D, 35 mm Build-Up | In distribution |
| 9952-22-13 | Size 22, 135 mm Stem Length | In distribution |
| 9977-18-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9952-20-13 | Size 20, 135 mm Stem Length | In distribution |
| 9980-120-22 | 12.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9923-93-45 | Length 93 mm | In distribution |
| 9983-240-34 | 24.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9965-73-04 | In distribution | |
| 9975-47-02 | In distribution | |
| 9975-05-18 | In distribution | |
| 9961-165-22 | Size 16.5, 170 mm Stem Length | In distribution |
| 9962-18-18 | Size 18, 185 mm Stem Length | In distribution |
| 9976-19-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 45 mm Build-Up | In distribution |
| 9981-240-32 | 24.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9982-14-13 | 14 mm Diameter, 135 mm Stem Length | In distribution |
| 9976-17-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 55 mm Build-Up | In distribution |
| 9922-18-23 | 18 mm Diameter, 235 mm Stem Length | In distribution |
| 9993-20-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size D, 55 mm Build-Up | In distribution |
| 9973-18-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9922-22-18 | 22 mm Diameter, 185 mm Stem Length | In distribution |
| 9961-135-32 | Size 13.5, 170 mm Stem Length | In distribution |
| 9973-20-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 35 mm Build-Up | In distribution |
| 9961-225-22 | Size 22.5, 170 mm Stem Length | In distribution |
| 9975-01-20 | In distribution | |
| 9953-93-40 | Length 93 mm | In distribution |
| 9971-17-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 45 mm Build-Up | In distribution |
| 9931-16-35 | 12/14 C-Ring Taper, 36 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9998-18-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 35 mm Build-Up | In distribution |
| 9978-17-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 45 mm Build-Up | In distribution |
| 9976-18-45 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9981-225-32 | 22.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9974-17-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 55 mm Build-Up | In distribution |
| 9955-17-10 | Size 17 | In distribution |
| 9983-255-32 | 25.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9983-135-33 | 13.5 mm Diameter, 220 mm Stem Length | In distribution |
| 00-9996-036-35 | 36 mm Neck Offset, 35 mm Build-Up | In distribution |
| 9943-16-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size AA Minus (-), 35 mm Build-Up | In distribution |
| 9994-19-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 45 mm Build-Up | In distribution |
| 9952-21-13 | Size 21, 135 mm Stem Length | In distribution |
| 9975-02-15 | Size 15.0 | In distribution |
| 9971-20-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 55 mm Build-Up | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961378 | 1996-10-08 |
| K952776 | 1996-02-14 |
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
1 of these is 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.