ABG
3 catalogue numbers from 4845-0208, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
3catalogue numbers in this listing
24510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), 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 |
| 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4845-0208 | Taper Connection: V40™ | In distribution |
| 4845-0107 | Side: RIGHT | In distribution |
| 4845-0202 | Size: 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103233 | 2011-02-03 |
| K071082 | 2007-09-13 |
| K070885 | 2007-05-16 |
| K063616 | 2006-12-20 |
| K052718 | 2005-10-27 |
| K051737 | 2005-07-19 |
| K051738 | 2005-07-19 |
| K051588 | 2005-07-12 |
| K041940 | 2005-02-11 |
| K041170 | 2004-11-09 |
| K040734 | 2004-08-25 |
| K031217 | 2003-05-23 |
| K023901 | 2003-01-28 |
| K022403 | 2002-10-17 |
| K022549 | 2002-09-23 |
| K022555 | 2002-08-26 |
| K013106 | 2002-04-03 |
| K003379 | 2000-11-30 |
| K003391 | 2000-11-28 |
| K003413 | 2000-11-24 |
| K002320 | 2000-09-14 |
| K001449 | 2000-08-04 |
| K993889 | 2000-02-11 |
| K991952 | 1999-06-29 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2022-01-14 | Class II | Under Investigation by firm | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling | 39 units Updated: 40 units | |
| 2022-01-14 | Class II | Under Investigation by firm | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling | 92 units Update: 40 units | |
| 2012-04-02 | Class II | Device Design | Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section. | 10, 983 units | 2013-06-13 |
| 2011-06-03 | Not classified | Labeling False and Misleading | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. | 13,263 units | 2013-11-13 |
| 2011-06-03 | Not classified | Labeling False and Misleading | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. | 1677 units | 2013-11-13 |
| 2011-06-03 | Not classified | Labeling False and Misleading | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. | 1951 units | 2013-11-13 |
| 2009-12-30 | Not classified | Process control | The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter. | 1 | 2012-09-14 |
| 2009-08-31 | Not classified | Error in labeling | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. | 2,876 | 2013-07-17 |
| 2009-08-31 | Not classified | Error in labeling | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. | 5,670 | 2013-07-17 |
| 2009-08-31 | Not classified | Error in labeling | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. | 3,510 | 2013-07-17 |
| 2009-08-31 | Not classified | Error in labeling | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. | 978 | 2013-07-17 |
| 2009-08-31 | Not classified | Error in labeling | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. | 1,362 | 2013-07-17 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203- all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties. | 2010-07-27 |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 203 – all varieties | 2010-07-27 |
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.