Z-1057-2009

Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long...

Name: Z-1057-2009 Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long...
Creator: Zimmer Inc.
Published: 2009-01-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-01-30 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01... on 2009-01-30. The reason FDA records is "The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone". 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-1057-2009
Status: Terminated
Initiated: 2009-01-30
Posted: 2009-04-02
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01. The device is utilized for a total elbow arthroplasty surgical procedure.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.
Quantity in commerce: 14,613 of all products
Distribution: Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
Product codes and lots: All lots.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)