Device recall
Z-0262-2018: Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc…
FDA device recall · Class II · NXTHERA
Key facts
| Recall number (Z-number) | Z-0262-2018 |
|---|---|
| Recall event | 77797 |
| Product | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to… |
| Product code | KNS |
| Recalling firm | NXTHERA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2018 |
| 510(k) numbers | K160417 |
| FEI number | 3007795803 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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