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Terminated

Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

FDA Recall Z-0318-2008 · Posted 2007-12-22

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-09-21
Date Terminated2009-06-30
Product Quantity6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008

Reason for Recall

Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.

Firm Action

Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.

Root Cause

Device Design

Distribution Pattern

Worldwide: USA, Canada and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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