The Triathlon Posteriorly Stabilized Femoral Component.
FDA device recall Z-0556-05 · posted 2005-02-24 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.
- Action taken
- Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- NPJ
- Quantity affected
- 386 UNITS
- Distribution
- The product is distributed to its branches/agencies and to hospitals nationwide.
- Date initiated
- 2004-10-27
- Date posted
- 2005-02-24
- Date terminated
- 2005-05-31
- Location
- Mahwah, NJ
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