Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
This recall has been terminated (originally issued December 14, 2010).
- Company
- Zimmer Inc.
- Recall Initiated
- November 15, 2010
- Posted
- December 14, 2010
- Terminated
- May 23, 2011
- Recall Number
- Z-0619-2011
- Quantity
- 3
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.
Distribution
Worldwide Distribution: US in the states of KS and UT, and the country of Canada.
Lot / Code Info
61438482
Root Cause
Employee error
Action Taken
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.