Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. |
|---|---|
| Recall Number | Z-0470-2013 |
| Classification | Class II |
| Code Info | Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31 |
| Product Distributed Qty | 8 |
| Reason For Recall | Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings. |
Event Detail
| Event Id | 63442 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Stryker Howmedica Osteonics Corp. |
| City | Mahwah |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution. |
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