| Class 2 Device Recall Biomet Dual Offset Broach Handle, Clamping Style | |
Date Initiated by Firm | March 31, 2009 |
Date Posted | June 01, 2009 |
Recall Status1 |
Terminated 3 on December 23, 2009 |
Recall Number | Z-1352-2009 |
Recall Event ID |
51693 |
Product Classification |
orthopedic instrument - Product Code LXH
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Product | Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty. |
Code Information |
Lots 066960, 141030, 147350, 316150, 401870, 401890, 523100, 604190, 829920, 899350 and 901600. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
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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 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 |
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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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