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.
FDA Recall Z-0767-04 · Posted 2004-07-20
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2004-03-16
Date Terminated2004-06-26
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.
Firm 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.
Root Cause
Other
Distribution Pattern
United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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