Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics
FDA device recall Z-0470-2013 · posted 2012-12-04 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 8
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-07-27
- Date posted
- 2012-12-04
- Date terminated
- 2015-09-30
- Location
- Mahwah, NJ
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