Z-0767-04

Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium...

Name: Z-0767-04 Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium...
Creator: Zimmer Inc.
Published: 2004-03-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2004-03-16 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone... on 2004-03-16. The reason FDA records is "Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants". 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-0767-04
Status: Terminated
Initiated: 2004-03-16
Posted: 2004-07-20
Terminated: 2004-06-26
Recalling firm: Zimmer GmbH
Product: Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.
Distribution: United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
Product codes and lots: Lot 60039452.

Product code JDC

K001989Class IICoonrad/morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. / cleared 2000-07-25

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)