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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer 4.5 Compression platebroad, 10 hole

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 Class 2 Recall
Zimmer 4.5 Compression platebroad, 10 hole
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on November 12, 2009
Recall Number Z-2179-2008
Recall Event ID 48631
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.
Code Information Lot 60985554.
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 plate or biocompatibility of the material with the body.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance.
Quantity in Commerce 7
Distribution International Distribution --- including Thailand.
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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