Recall Z-0768-04 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer Inc.
Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-02.
| Date | Jul 20, 2004 (initiated Mar 16, 2004) |
| Status | Terminated |
| Reason | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.