Biomet, Inc. Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.