Z-2204-2010

Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component

Name: Z-2204-2010 Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component
Creator: Biomet, Inc.
Published: 2010-04-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-04-20 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component on 2010-04-20. The reason FDA records is "A knee implant labeled as left was opened and the package actually contained a right knee implant". 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-2204-2010
Status: Terminated
Initiated: 2010-04-20
Posted: 2010-08-10
Terminated: 2011-01-19
Recalling firm: Zimmer GmbH
Product: Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A knee implant labeled as left was opened and the package actually contained a right knee implant.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
Quantity in commerce: 5
Distribution: 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan
Product codes and lots: M402080.

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)