Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.
FDA device recall Z-1353-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 178 of all products.
- Distribution
- Nationwide, Canada and Finland.
- Date initiated
- 2009-03-31
- Date posted
- 2009-06-01
- Date terminated
- 2009-12-23
- Location
- Warsaw, IN
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