Device recall
Z-2077-2021: BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component…
FDA device recall · Class II · Axonics Modulation Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-2077-2021 |
|---|---|
| Recall event | 88141 |
| Product | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476 |
| Product code | LNM |
| Recalling firm | Axonics Modulation Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2022 |
| PMA numbers | P170023 |
| FEI number | 3002968685 |
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