Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF R

FDA device recall Z-0519-2009 · posted 2009-01-07 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

41 of all products.

Distribution

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

Date initiated

2008-07-18

Date posted

2009-01-07

Date terminated

2009-07-07

Location

Warsaw, IN