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