Device recall
Z-1154-2021: HNM Disposable Bipolar Ablators - Product Usage: intended to be used for…
FDA device recall · Class II · Bovie Medical Corporation
Key facts
| Recall number (Z-number) | Z-1154-2021 |
|---|---|
| Recall event | 87274 |
| Product | HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. |
| Product code | GEI |
| Recalling firm | Bovie Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161558 |
| FEI number | 3007593903 |
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