Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall Z-0518-2009 · Posted 2009-01-07
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-07-18
Date Terminated2009-07-07
Product Quantity41 of all products.
Reason for Recall
The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
Firm Action
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
Distribution Pattern
Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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