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U.S. Department of Health and Human Services

Class 2 Device Recall TRIATHLON TS KNEE SYSTEM

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  Class 2 Device Recall TRIATHLON TS KNEE SYSTEM see related information
Date Initiated by Firm December 10, 2009
Date Posted February 01, 2010
Recall Status1 Terminated 3 on August 28, 2012
Recall Number Z-0759-2010
Recall Event ID 54138
510(K)Number K070095  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.

The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Code Information Catalog number: 5512-F-402; Lot codes: XAWZ and YGYP.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
Quantity in Commerce 5
Distribution Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom 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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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