Z-2945-2011

Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A...

Name: Z-2945-2011 Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A...
Creator: Biomet, Inc.
Published: 2011-07-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-07-06 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral... on 2011-07-06. The reason FDA records is "The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless". 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-2945-2011
Status: Terminated
Initiated: 2011-07-06
Posted: 2011-08-04
Terminated: 2012-09-26
Recalling firm: Zimmer GmbH
Product: Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.
Quantity in commerce: 8
Distribution: Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
Product codes and lots: Part # 183132. Lot # 947480.

Product code JWH

K023546Class IIMaxim Accel Knee SystemBiomet, Inc. / cleared 2003-01-17

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)