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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Unicompartmental Knee System headed screw

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 Class 3 Recall
Zimmer Unicompartmental Knee System headed screw
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on December 17, 2008
Recall Number Z-2300-2008
Recall Event ID 48716
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
Code Information Lot 60954069.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
Quantity in Commerce 5
Distribution Florida, China and India.
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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