—#66623

Product

Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Number: 038690.

Why it was recalled

The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.

Root cause (FDA determination)

Process control

Action the firm took

Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Timeline

Recall initiated: 2007-10-18
Posted by FDA: 2008-02-05
Terminated: 2008-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.