Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2012 - (Recall #: Z-0470-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 27, 2012

Date Posted: December 12, 2012

Recall Number: Z-0470-2013

Event ID: 63442

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.

Status: Terminated

Product Quantity: 8

Code Information:

Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated