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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Echo Hip Instrumentation Exact Slotted Stem Inserter

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 Class 2 Recall
Biomet Echo Hip Instrumentation Exact Slotted Stem Inserter
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on June 30, 2009
Recall Number Z-1318-2008
Recall Event ID 46707
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610.
Code Information Lots 218606, 218614 and 217595.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
The instrument will not mate with its stem.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Biomet distributors were notified via recall letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments.
Quantity in Commerce 78
Distribution Nationwide.
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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