—#114071

Product

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2012-07-27
Posted by FDA: 2012-12-04
Terminated: 2015-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.