FDA Device recall Z-2516-2021
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560 by Aesculap Implant Systems, citing malfunction- loosening of the implant resulting in a potential revision surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2516-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-19 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
Reason
Malfunction- loosening of the implant resulting in a potential revision surgery
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2516-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.