Z-1375-2008

Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc...

Name: Z-1375-2008 Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc...
Creator: Biomet, Inc.
Published: 2008-02-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-02-12 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448 on 2008-02-12. The reason FDA records is "Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1375-2008
Status: Terminated
Initiated: 2008-02-12
Posted: 2008-07-25
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
Quantity in commerce: 4
Distribution: Worldwide: USA and Australia
Product codes and lots: Lot 743430.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)