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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Howmedica Osteonics Corp.

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  Class 2 Device Recall Stryker Howmedica Osteonics Corp. see related information
Date Initiated by Firm July 27, 2012
Date Posting Updated December 04, 2012
Recall Status1 Terminated 3 on September 30, 2015
Recall Number Z-0469-2013
Recall Event ID 63442
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Stryker Orthopaedics
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

Code Information Class I, 510(k) exempt

Catalog Number: 6543-1-600

Lot Number; NE1WR1.
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
Manufacturer 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.
FDA Determined
Cause 2
Error in labeling
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 7 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.