Device recall
Z-2515-2021: Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-2515-2021 |
|---|---|
| Recall event | 88325 |
| Product | Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z… |
| 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