Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
37 catalogue numbers from 00-7712-004-64, 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
37catalogue 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) | K060040 |
| Record published | 2016-07-18 |
| Record revised | 2023-04-04 (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 |
| Distribution end date | 2017-05-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-7712-004-64 | 0 mm Rasp, Size 4 | In distribution |
| 9363-28-067 | Size 28mm/67mm | In distribution |
| 9362-22-053 | Size 22 mm/53 mm | In distribution |
| 9363-28-065 | Size 28mm/65mm | In distribution |
| 9362-22-065 | Size 22 mm/65 mm | In distribution |
| 9363-28-059 | Size 28mm/59mm | In distribution |
| 9666-44-004 | 12/14 Taper Trial Head, 44 mm, -4.0 mm Neck | In distribution |
| 9362-26-053 | Size 26 mm/53 mm | In distribution |
| 9666-38-004 | 12/14 Taper Trial Head, 38 mm, -4.0 mm Neck | In distribution |
| 9363-26-061 | Size 26mm/61mm | In distribution |
| 00-7712-010-64 | 0 mm Rasp, Size 10 | In distribution |
| 7351-30-014 | Diameter, 14 mm | In distribution |
| 9364-99-141 | 28 mm Protrusio Insert Trials Tray | In distribution |
| 9666-38-000 | 12/14 Taper Trial Head, 38 mm, Neutral Neck | In distribution |
| 9362-38-063 | Size 38 mm/63 mm | In distribution |
| 9362-28-055 | Size 28 mm/55 mm | In distribution |
| 00-7712-012-64 | 0 mm Rasp, Size 12.5 | In distribution |
| 7351-30-010 | Diameter, 10 mm | In distribution |
| 9363-22-053 | Size 22mm/53mm | In distribution |
| 9363-32-055 | Size 32mm/55mm | In distribution |
| 7351-30-017 | Diameter, 17 mm | In distribution |
| 9363-28-063 | Size 28mm/63mm | In distribution |
| 9363-22-063 | Size 22mm/63mm | In distribution |
| 9362-38-067 | Size 38mm/67mm | In distribution |
| 9362-38-061 | Size 38 mm/61 mm | In distribution |
| 9362-22-047 | Size 22 mm/47 mm | In distribution |
| 9363-26-059 | Size 26mm/59mm | In distribution |
| 9362-28-067 | Size 28 mm/67 mm | In distribution |
| 9360-00-042 | Size 42 mm | Withdrawn |
| 9354-20-007 | Size 7 | Withdrawn |
| 9366-38-004 | 38 mm I.D. Insert Impactor | Withdrawn |
| 9360-00-066 | Size 66 mm | Withdrawn |
| 9366-28-012 | 28 mm Insert Chamfer Impactor | Withdrawn |
| 9360-00-044 | Size 44 mm | Withdrawn |
| 9354-20-199 | Size 00 | Withdrawn |
| 9360-00-046 | Size 46 mm | Withdrawn |
| 9360-00-038 | Size 38 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| 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 |
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
9 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 | 2023-02-27 | 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 | |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2016-02-11 | Class II | Under Investigation by firm | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rathe | 9 units | 2016-12-01 |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 1908 | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-05-23 | Class II | Packaging | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | 1487 units | 2015-03-06 |
| Zimmer, Inc. | 510(k) number | 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 1000 | 2014-04-16 |
| Centerpulse Orthopedics, Inc. | 510(k) number | 2003-09-30 | Not classified | Other | Compalints of acetabular shell disassociating with the bone. | 145 units | 2004-11-04 |
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 |
| 2009-05-15 | Not classified | Process control | The threads on the screw are incomplete/non-functional. | 10 | 2009-11-12 |
| 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.