Z-0697-2012

Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use...

Name: Z-0697-2012 Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use...
Creator: Biomet, Inc.
Published: 2011-10-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-10-04 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee... on 2011-10-04. The reason FDA records is "Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0697-2012
Status: Terminated
Initiated: 2011-10-04
Posted: 2012-01-11
Terminated: 2013-04-08
Recalling firm: Zimmer GmbH
Product: Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.
Distribution: Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
Product codes and lots: Part 184702, Lot 107600, 136480, 136490, 190360, 248230, 312420, 312430, 344660, 413600, 413610, 485560, 517210, 517240, 614990, 644400, 678050, and 732780

Product code JWH

K040770Class IIVanguard Patella ComponentsBiomet Manufacturing, Inc. / cleared 2004-04-22

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)