Z-0289-2009

Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet...

Name: Z-0289-2009 Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet...
Creator: Biomet, Inc.
Published: 2008-09-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-09-22 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis... on 2008-09-22. The reason FDA records is "The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67"". 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-0289-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2008-11-21
Terminated: 2009-09-22
Recalling firm: Zimmer GmbH
Product: Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem. Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).
Quantity in commerce: 11
Distribution: Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.
Product codes and lots: Lots 713910, 806560, 816560 and 871750.

Product code JWH

K041046Class IIMaxim Accel (Vanguard) Ps+ BearingsBiomet, Inc. / cleared 2004-05-21

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)