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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 January 23, 2008
Recall Status1 Terminated on September 22, 2009
Recall Number Z-0115-2008
Recall Event ID 45855
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), Biomet Orthopedics, Inc., Warsaw, IN. 46581
Code Information Lots 095112 and 474660.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
Manufacturer Reason
for Recall
Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction.
FDA Determined
Cause 2
Action Consignees were notified by Urgent Medical Device Correction Notice (letter) dated 9/4/07 to discontinue use of the instruments and to return them for evaluation.
Quantity in Commerce 22
Distribution Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.
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.