Recall Z-0469-2013— Stryker Howmedica Osteonics Corp.

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-07-27, terminated 2015-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Stryker Howmedica Osteonics Corp.

Classification

Class II

Status

Terminated

Initiated

2012-07-27

Terminated

2015-09-30

Firm location

Mahwah, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.