Class 2 Device Recall Biomet Magnum Straight Insert Handle

• Date Initiated by Firm: June 14, 2007
• Date Posted: August 07, 2007
• Recall Status: Terminated on December 12, 2007
• Recall Number: Z-1151-2007
• Recall Event ID: 38121
• Product Classification: Acetabular component - 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 IN 46581-0587
• For Additional Information Contact: 574-267-6639
• 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: Other
• 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 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.