Z-0319-2008

Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN

Name: Z-0319-2008 Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN
Creator: Biomet, Inc.
Published: 2007-09-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-09-21 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN on 2007-09-21. The reason FDA records is "Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0319-2008
Status: Terminated
Initiated: 2007-09-21
Posted: 2007-12-22
Terminated: 2009-06-30
Recalling firm: Zimmer GmbH
Product: Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008
Distribution: Worldwide: USA, Canada and Japan.
Product codes and lots: All units including lots 429900, 642100 and 647700.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)