Recall Z-1353-2009 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.
| Date | Jun 1, 2009 (initiated Mar 31, 2009) |
| Status | Terminated |
| Reason | The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach. |
| Root 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 | 178 of all products. |
| Distribution | Nationwide, Canada and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.