Class 2 Device Recall Biomet Dual Offset Broach Handle, Clamping Style

• Date Initiated by Firm: March 31, 2009
• Date Posted: June 01, 2009
• Recall Status: Terminated on December 23, 2009
• Recall Number: Z-1353-2009
• Recall Event ID: 51693
• Product Classification: orthopedic instrument - Product Code LXH
• Product: Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.
• Code Information: Lots 069990, 141040, 147360, 316160, 401900, 401910, 417580, 523120, 605420, 829970, 873000, 901610 and 930110.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: Mary Johnson; 574-372-3983
• Manufacturer Reason for Recall: The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
• FDA Determined Cause: Device Design
• Action: Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.
• Quantity in Commerce: 178 of all products.
• Distribution: Nationwide, Canada 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.