—#72524

Product

Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 991680.

Why it was recalled

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

Root cause (FDA determination)

Process control

Action the firm took

Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.

Timeline

Recall initiated: 2008-07-18
Posted by FDA: 2009-01-07
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72524. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.