Device recall
Z-2516-2021: Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-2516-2021 |
|---|---|
| Recall event | 88325 |
| 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 |
| Product code | HRY |
| Recalling firm | Aesculap Implant Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2025 |
| 510(k) numbers | K081293, K131167 |
| FEI number | 2916714 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database