Class 2 Device Recall Biomet Magnum Straight Insert Handle

• Date Initiated by Firm: September 04, 2007
• Date Posted: January 23, 2008
• Recall Status: Terminated on September 22, 2009
• Recall Number: Z-0115-2008
• Recall Event ID: 45855
• Product Classification: Inserter Handle - 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/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46581-0587
• For Additional Information Contact: 800-348-9500 Ext. 1305
• 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: 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

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.