Z-0255-2008

Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product...

Name: Z-0255-2008 Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product...
Creator: Biomet, Inc.
Published: 2007-09-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-09-18 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN... on 2007-09-18. The reason FDA records is "Mislabeled as to size: the package actaully contained a 71 mm tray". 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-0255-2008
Status: Terminated
Initiated: 2007-09-18
Posted: 2007-11-24
Terminated: 2008-06-04
Recalling firm: Zimmer GmbH
Product: Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled as to size: the package actaully contained a 71 mm tray.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.
Quantity in commerce: 7
Distribution: Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
Product codes and lots: Lot 626520.

Product code JWH

K915132Class IIMck Maximum Congruent Knee) Knee SystemBiomet, Inc. / cleared 1992-02-11

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)