Device recall
Z-1146-2020: Revanesse Versa, PN40081
FDA device recall · Class II · Prollenium Medical Technologies Inc.
Key facts
| Recall number (Z-number) | Z-1146-2020 |
|---|---|
| Recall event | 83834 |
| Product | Revanesse Versa, PN40081 |
| Product code | LMH |
| Recalling firm | Prollenium Medical Technologies Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2024 |
| PMA numbers | P160042 |
| FEI number | 3004423487 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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