Z-0877-2009

Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw...

Name: Z-0877-2009 Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw...
Creator: Biomet, Inc.
Published: 2008-12-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-12-18 / Terminated

FDA source

Biomet, Inc. began a recall of Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485154. A manual surgical instrument... on 2008-12-18. The reason FDA records is "Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0877-2009
Status: Terminated
Initiated: 2008-12-18
Posted: 2009-01-13
Terminated: 2010-01-20
Recalling firm: Zimmer GmbH
Product: Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
FDA root cause: Other
Action: Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.
Quantity in commerce: 444 of all products
Distribution: Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
Product codes and lots: Lots 083940 and 132602.

Product code HTZ

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)