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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Femoral Sizer

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 Class 2 Recall
Triathlon Femoral Sizer
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on September 24, 2008
Recall Number Z-1864-2008
Recall Event ID 48200
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur.
Code Information Catalog Number: 6541-1-603 All lots (ecxept lot codes NMZC01, NMYV01, NMYW03.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively.
FDA Determined
Cause 2
DESIGN: Device Design
Action Letters were sent to all affected Stryker Branches/Agencies on May 27, 2005. Letters requested that each branch examine the inventory and hospitals locations to identify the instruments. Contact James Young at 201-831-5110, Brian Coughlin at 210-831-5665 or Rita Intorrella at 201-831-5825 if you have questions.
Quantity in Commerce 560 units
Distribution To Stryker branches/agencies worldwide.
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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