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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Dual Offset Broach Handle, Clamping Style

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 Class 2 Recall
Biomet Dual Offset Broach Handle, Clamping Style
see related information
Date Posted June 01, 2009
Recall Status1 Terminated on December 23, 2009
Recall Number Z-1352-2009
Recall Event ID 51693
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.
Code Information Lots 066960, 141030, 147350, 316150, 401870, 401890, 523100, 604190, 829920, 899350 and 901600.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
For Additional Information Contact Mary Johnson
574-372-3983
Manufacturer Reason
for Recall
The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
FDA Determined
Cause 2
DESIGN: Device Design
Action Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.
Quantity in Commerce 178 of all products.
Distribution Nationwide, Canada and Finland.
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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