ZMR®
103 catalogue numbers from 9997-18-55, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
103catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWZ |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113296 |
| Record published | 2015-09-17 |
| Record revised | 2020-06-19 (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 103 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9997-18-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 9953-103-45 | Length 103 mm | In distribution |
| 9994-21-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size E, 45 mm Build-Up | In distribution |
| 9977-17-55 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 55 mm Build-Up | In distribution |
| 9976-17-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size A 35 mm Build-Up | In distribution |
| 9965-01-18 | In distribution | |
| 9981-210-22 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9981-195-22 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9981-180-33 | 18.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9994-23-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 45 mm Build-Up | In distribution |
| 9953-103-40 | Length 103 mm | In distribution |
| 9975-02-18 | Size 18.0 | In distribution |
| 9982-19-13 | 19 mm Diameter, 135 mm Stem Length | In distribution |
| 9971-19-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 45 mm Build-Up | In distribution |
| 9998-19-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size C, 35 mm Build-Up | In distribution |
| 9921-255-34 | 25.5 mm Diameter, 260 mm Stem Length | In distribution |
| 9994-17-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size A, 55 mm Build-Up | In distribution |
| 9975-31-02 | In distribution | |
| 9962-22-23 | Size 22, 235 mm Stem Length | In distribution |
| 9980-210-32 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-225-33 | 22.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9976-21-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size E 35 mm Build-Up | In distribution |
| 9965-20-18 | Size 20 | In distribution |
| 9921-210-32 | 21.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9971-23-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 45 mm Build-Up | In distribution |
| 9961-120-22 | Size 12.0, 170 mm Stem Length | In distribution |
| 9980-135-33 | 13.5 mm Diameter, 220 mm Stem Length | In distribution |
| 00-9924-040-78 | 40 mm Neck Offset, 78 mm Build-Up | In distribution |
| 9962-20-23 | Size 20, 235 mm Stem Length | In distribution |
| 9973-20-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size D 45 mm Build-Up | In distribution |
| 9983-255-34 | 25.5 mm Diameter, 260 mm Stem Length | In distribution |
| 9994-18-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size B, 55 mm Build-Up | In distribution |
| 9970-16-36 | 12/14 C-Ring Taper, 36 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9975-38 | In distribution | |
| 00-9975-007-16 | AA Body | In distribution |
| 9961-195-21 | Size 19.5, 115 mm Stem Length | In distribution |
| 9981-135-32 | 13.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9991-23-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 45 mm Build-Up | In distribution |
| 9922-21-13 | 21 mm Diameter, 135 mm Stem Length | In distribution |
| 9961-210-22 | Size 21.0, 170 mm Stem Length | In distribution |
| 9981-135-22 | 13.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-210-34 | 21.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9993-23-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 45 mm Build-Up | In distribution |
| 9970-19-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 35 mm Build-Up | In distribution |
| 9973-17-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size A 35 mm Build-Up | In distribution |
| 9978-16-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size AA 35 mm Build-Up | In distribution |
| 9996-20-35 | 12/14 Neck Taper, 40 mm Neck Offset, Size D, 35 mm Build-Up | In distribution |
| 9961-180-33 | Size 18.0, 220 mm Stem Length | In distribution |
| 9997-18-45 | 12/14 Neck Taper, 40 mm Neck Offset, Size B, 45 mm Build-Up | In distribution |
| 9952-21-23 | Size 21, 235 mm Stem Length | In distribution |
| 9991-19-45 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 45 mm Build-Up | In distribution |
| 9975-02-16 | Size 16.5 | In distribution |
| 9981-195-32 | 19.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9990-17-40 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 35 mm Build-Up | In distribution |
| 9971-18-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size B 45 mm Build-Up | In distribution |
| 9922-21-23 | 21 mm Diameter, 235 mm Stem Length | In distribution |
| 9971-21-55 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size E 55 mm Build-Up | In distribution |
| 9961-240-22 | Size 24.0, 170 mm Stem Length | In distribution |
| 9922-24-18 | 24 mm Diameter, 185 mm Stem Length | In distribution |
| 9991-23-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size F, 55 mm Build-Up | In distribution |
| 9983-210-33 | 21.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9922-17-13 | 17 mm Diameter, 135 mm Stem Length | In distribution |
| 9974-19-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size C 45 mm Build-Up | In distribution |
| 9982-14-18 | 14 mm Diameter, 185 mm Stem Length | In distribution |
| 9921-180-33 | 18.0 mm Diameter, 220 mm Stem Length | In distribution |
| 9981-180-32 | 18.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9981-150-32 | 15.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9975-05-17 | In distribution | |
| 9941-16-35 | 12/14 Neck Taper, 36 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9970-23-40 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size F 35 mm Build-Up | In distribution |
| 9982-17-23 | 17 mm Diameter, 235 mm Stem Length | In distribution |
| 9980-225-32 | 22.5 mm Diameter, 170 mm Stem Length | In distribution |
| 00-9975-007-04 | In distribution | |
| 9983-180-32 | 18.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9962-19-18 | Size 19, 185 mm Stem Length | In distribution |
| 9983-150-34 | 15.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9983-225-33 | 22.5 mm Diameter, 220 mm Stem Length | In distribution |
| 9922-19-23 | 19 mm Diameter, 235 mm Stem Length | In distribution |
| 9975-33-02 | In distribution | |
| 9982-99-02 | In distribution | |
| 9981-120-21 | 12.0 mm Diameter, 115 mm Stem Length | In distribution |
| 9983-225-34 | 22.5 mm Diameter, 260 mm Stem Length | In distribution |
| 9961-240-32 | Size 24.0, 170 mm Stem Length | In distribution |
| 9923-103-40 | Length 103 mm | In distribution |
| 9973-21-35 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size E 35 mm Build-Up | In distribution |
| 9982-18-18 | 18 mm Diameter, 185 mm Stem Length | In distribution |
| 9996-17-55 | 12/14 Neck Taper, 40 mm Neck Offset, Size A, 55 mm Build-Up | In distribution |
| 00-9975-007-23 | F Body | In distribution |
| 9922-17-23 | 17 mm Diameter, 235 mm Stem Length | In distribution |
| 9980-165-32 | 16.5 mm Diameter, 170 mm Stem Length | In distribution |
| 9974-23-45 | 12/14 C-Ring Taper, 46 mm Neck Offset, Size F 45 mm Build-Up | In distribution |
| 9990-16-36 | 12/14 Neck Taper, 36 mm Neck Offset, Size AA, 35 mm Build-Up | In distribution |
| 9976-19-35 | 12/14 C-Ring Taper, 40 mm Neck Offset, Size C 35 mm Build-Up | In distribution |
| 9962-14-18 | Size 14, 185 mm Stem Length | In distribution |
| 9952-20-23 | Size 20, 235 mm Stem Length | In distribution |
| 9981-165-21 | 16.5 mm Diameter, 115 mm Stem Length | In distribution |
| 9975-01-21 | In distribution | |
| 9952-20-18 | Size 20, 185 mm Stem Length | In distribution |
| 9991-19-55 | 12/14 Neck Taper, 46 mm Neck Offset, Size C, 55 mm Build-Up | In distribution |
| 9980-120-32 | 12.0 mm Diameter, 170 mm Stem Length | In distribution |
| 9921-195-34 | 19.5 mm Diameter, 260 mm Stem Length | In distribution |
| 9921-180-34 | 18.0 mm Diameter, 260 mm Stem Length | In distribution |
| 9983-150-32 | 15.0 mm Diameter, 170 mm Stem Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 159 |
| Instrument | Howmedica Osteonics Corp | 139 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Zimmer, Inc. | 69 |
| Arcos Modular Revision System | Biomet Orthopedics | 66 |
| Pinnacle | Depuy Orthopaedics, Inc. | 52 |
| System 12 | Howmedica Osteonics Corp | 47 |
| Restoration | Howmedica Osteonics Corp | 46 |
| Redapt | Smith & Nephew, Inc. | 43 |
| R3 | Smith & Nephew, Inc. | 41 |
| Trident | Howmedica Osteonics Corp | 38 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 37 |
| G7® | Biomet Orthopedics | 37 |
Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101730 | 2010-12-03 |
| K072121 | 2008-01-07 |
| K071718 | 2007-07-13 |
| K021826 | 2002-12-20 |
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 |
|---|---|---|---|---|---|
| 2012-08-27 | Class II | Labeling Change Control | Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton. | 1 | 2013-08-27 |
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 |
|---|---|---|---|
| P960054 | 1997-06-19 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. |
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.