Recalls / —

—#81002

Product

Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lots 069990, 141040, 147360, 316160, 401900, 401910, 417580, 523120, 605420, 829970, 873000, 901610 and 930110.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

Nationwide, Canada and Finland.

Timeline

Recall initiated

2009-03-31

Posted by FDA

2009-06-01

Terminated

2009-12-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #81002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.