Device recall
Z-1583-2018: DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6…
FDA device recall · Class II · DeRoyal Industries Inc
Key facts
| Recall number (Z-number) | Z-1583-2018 |
|---|---|
| Recall event | 79939 |
| Product | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical |
| Product code | GEI |
| Recalling firm | DeRoyal Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2018 |
| 510(k) numbers | K940909 |
| FEI number | 1043214 |
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