Restoration Modular Hip System; Proximal Cone Body; 23 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
Recall
- Recall Number
- Z-2161-2009
- Event Number
- 52713
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- LZO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 26, 2009
- Posted
- September 14, 2009
- Terminated
- July 27, 2010
- Address
- 325 Corporate Drive, Mahwah, NJ, 07430
Description
Restoration Modular Hip System; Proximal Cone Body; 23 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
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
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.
Worldwide Distribution
203 - all varieties.