Device product
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
Z-1575-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 71009
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1575-2015
Official wording
Reason: The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
Code information: Part #00-5990-036-10; lot 62815809
Distribution pattern: Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
Derived failure modes
-
Unknown
The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery