Restoration Modular Hip System; Proximal Cone Body; 31 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cemen
FDA device recall Z-2165-2009 · posted 2009-09-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 203 - all varieties.
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-06-26
- Date posted
- 2009-09-14
- Date terminated
- 2010-07-27
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2 PIECE MODULAR HIP STEM (K013106) | Howmedica Osteonics Corp. | 2002-04-03 |