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U.S. Department of Health and Human Services

Class 2 Device Recall Total Knee Joint Replacement Prosthesis

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  Class 2 Device Recall Total Knee Joint Replacement Prosthesis see related information
Date Initiated by Firm September 21, 2006
Date Posted January 08, 2009
Recall Status1 Terminated 3 on January 09, 2009
Recall Number Z-0579-2009
Recall Event ID 49573
510(K)Number K051380  
Product Classification Knee joint - Product Code MBH
Product Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile.
Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland.
The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Code Information Lot Code SANMH
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.
FDA Determined
Cause 2
Process change control
Action Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.
Quantity in Commerce 10
Distribution PA, GA, AL, WI, UT, and OR.
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.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = HOWMEDICA OSTEONICS CORP