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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Magnum Straight Insert Handle

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 Class 2 Recall
Biomet Magnum Straight Insert Handle
see related information
Date Posted August 07, 2007
Recall Status1 Terminated on December 12, 2007
Recall Number Z-1151-2007
Recall Event ID 38121
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)
Code Information Lots 824920, 559080, 509420, 493210, 221060, 167220 and 129030. .
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
Manufacturer Reason
for Recall
The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.
Quantity in Commerce 94
Distribution World wide: USA, Australia, 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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