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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon TS Femoral Trial

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 Class 2 Recall
Triathlon TS Femoral Trial
see related information
Date Posted July 26, 2008
Recall Status1 Terminated on October 25, 2010
Recall Number Z-1576-2008
Recall Event ID 47400
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog Number: 5512-T-301 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
Code Information Code Numbers N4TMPD, PDAMPD, WEWC
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall
Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.
Quantity in Commerce 18
Distribution Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.
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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