Recall Z-0619-2011 ยท HWT Template
Zimmer Inc.
Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
| Date | Dec 14, 2010 (initiated Nov 15, 2010) |
| Status | Terminated |
| Reason | Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts. |
| Root cause | Employee error |
| Action | Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall. |
| Quantity | 3 |
| Distribution | Worldwide Distribution: US in the states of KS and UT, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.