Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION… — Class II medical device recall Z-0469-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-12-12. Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Ti
| Recall number | Z-0469-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2012-07-27 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2015-09-30 |
| Quantity | 7 units |
| Lot numbers | NE1WR1 |
| Model numbers | 6543-1-600 |
Product
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;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 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. Made in USA
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.