Z-0706-2008

Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

Name: Z-0706-2008 Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
Creator: Biomet, Inc.
Published: 2007-12-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-12-12 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581 on 2007-12-12. The reason FDA records is "Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa". 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-0706-2008
Status: Terminated
Initiated: 2007-12-12
Posted: 2008-01-31
Terminated: 2008-06-11
Recalling firm: Zimmer GmbH
Product: Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.
Quantity in commerce: 8
Distribution: Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.
Product codes and lots: Lot Number: 448530.

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)