Recall Z-2144-2009 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Stryker Howmedica Osteonics Corp.
Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants. Stryker Orthopaedics. Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
| Date | Sep 14, 2009 (initiated Jun 26, 2009) |
| Status | Terminated |
| Reason | 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 this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970. |
| Quantity | 24 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071471 | CORIN ADAPTOR SLEEVE Howmedica Osteonics Corp., Sep 10, 2007 |