Z-1361-2008

Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw...

Name: Z-1361-2008 Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw...
Creator: Biomet, Inc.
Published: 2008-02-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-02-12 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used... on 2008-02-12. The reason FDA records is "The instrument's sizing line is in the wrong place". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1361-2008
Status: Terminated
Initiated: 2008-02-12
Posted: 2008-03-28
Terminated: 2009-06-26
Recalling firm: Zimmer GmbH
Product: Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.
Product code: HWT Template
Reason for recall: The instrument's sizing line is in the wrong place.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.
Quantity in commerce: 35 (31 to U.S. and 4 international).
Distribution: Worldwide: USA, Canada, China and Finland.
Product codes and lots: Lot Number-212910.

Product code HWT

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)