Z-0646-2010

Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered...

Name: Z-0646-2010 Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered...
Creator: Biomet, Inc.
Published: 2009-12-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-12-01 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use... on 2009-12-01. The reason FDA records is "The locking hook tabs may fracture and fragments remain in the patient post-operatively". 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-0646-2010
Status: Terminated
Initiated: 2009-12-01
Posted: 2010-01-15
Terminated: 2010-10-18
Recalling firm: Zimmer GmbH
Product: Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The locking hook tabs may fracture and fragments remain in the patient post-operatively.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.
Quantity in commerce: 92
Distribution: Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.
Product codes and lots: Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)