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Class 2 Device Recall Biomet Magnum Straight Insert Handle |
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Date Initiated by Firm |
September 04, 2007 |
Date Posted |
January 23, 2008 |
Recall Status1 |
Terminated 3 on September 22, 2009 |
Recall Number |
Z-0115-2008 |
Recall Event ID |
45855 |
Product Classification |
Inserter Handle - Product Code LXH
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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/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
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For Additional Information Contact |
800-348-9500 Ext. 1305
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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.
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FDA Determined Cause 2 |
Other |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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