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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet brand Modular Microplasty Cup Inserter

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 Class 2 Recall
Biomet brand Modular Microplasty Cup Inserter
see related information
Date Posted October 24, 2008
Recall Status1 Terminated on September 22, 2009
Recall Number Z-0181-2009
Recall Event ID 49464
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
Code Information Lot 097525, 097526, 532370 and 532810.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
The pin and clip may fracture during use.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.
Quantity in Commerce 85
Distribution Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.
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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