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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Biomet Dual Offset Broach Handle, Clamping Style see related information
Date Initiated by Firm March 31, 2009
Date Posted June 01, 2009
Recall Status1 Terminated 3 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/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact Mary Johnson
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 2
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.