FDA Device

Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.

Hazard

The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.

What You Should Do

Remedy

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.

Products

Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.
Brand
Biomet, Inc.
UPC
Lots 066960, 141030, 147350, 316150, 401870, 401890, 523100, 604190, 829920, 899350 and 901600.

Units Affected

178 of all products.