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U.S. Department of Health and Human Services

Class 2 Device Recall 36 TCG Upper Tray

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  Class 2 Device Recall 36 TCG Upper Tray see related information
Date Initiated by Firm May 15, 2009
Date Posted July 15, 2009
Recall Status1 Terminated 3 on April 05, 2010
Recall Number Z-1619-2009
Recall Event ID 52191
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile;
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.

For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
Code Information Catalog Number: 6543-8-014.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5790
Manufacturer Reason
for Recall		 The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
FDA Determined
Cause 2		 Process change control
Action Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069. Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.
Quantity in Commerce 26
Distribution Worldwide Distribution -- US and Canada.
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.
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