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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon MIS AP Sizer Body

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 Class 2 Recall
Triathlon MIS AP Sizer Body
see related information
Date Posted December 11, 2007
Recall Status1 Terminated on January 18, 2008
Recall Number Z-0448-2008
Recall Event ID 45540
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
Code Information Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right; All lot codes
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
Manufacturer Reason
for Recall
Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.
FDA Determined
Cause 2
DESIGN: Device Design
Action Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.
Quantity in Commerce 2,868 units total for Recalls Z-0448-0450-2008
Distribution Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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