FDA Device recall Z-1575-2015
NexGen Augment
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of NexGen Augment by Zimmer, citing 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 compone….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1575-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-02 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | FL, IL, IN, MN |
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.
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
Identifiers
| code_info | Part #00-5990-036-10; lot 62815809 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1575-2015%22
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