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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm July 02, 2013
Date Posted August 29, 2013
Recall Status1 Terminated 3 on April 27, 2016
Recall Number Z-2130-2013
Recall Event ID 65902
Product Classification Clamp, surgical, general & #38; plastic surgery - Product Code GDJ
Product Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
Code Information Catalog #6541-2-609 All lot codes
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
Manufacturer Reason
for Recall
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
FDA Determined
Cause 2
Device Design
Action Stryker Orthopaedics sent an Urgent Medical Device Correction letter dated July 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by t he customers. Customers are advised of the issue, potential hazards and risk mitigation factors. Customers are asked to complete the attached form and fax to 855-251-3635. Any questions should be directed to (201) 972-2100. All letters included a Product Correction Bulletin.
Quantity in Commerce 10,537 units
Distribution Nationwide 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.