| Date Posted |
December 04, 2012 |
| Recall Number |
Z-0470-2013 |
| 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. |
| Code Information |
Class I, 510(k) exempt
Catalog Number: 6543-2-600
Lot Number: P1S43, P2A31
|
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430 |
| For Additional Information Contact |
Colleen O'Meara
201-831-5523
|
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 |
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. |
| Quantity in Commerce |
8 |
| Distribution |
Worldwide Distribution. |
| |
|
