FDA Recall
Terminated
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
Recall: Z-0650-2007
·
Initiated October 10, 2006
Recall
- Recall Number
- Z-0650-2007
- Event Number
- 37069
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 10, 2006
- Posted
- March 28, 2007
- Terminated
- December 4, 2007
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
Reason
The device was cut to an incorrect angle, which may result in an incorrect bone cut.
Action
Product was removed from customer location during visit on 10/10/2006.
Distribution
One medical facility in Michigan.
Quantity
1