Device recall
Z-1983-2013: GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm…
FDA device recall · Class II · Gyrus Medical, Inc
Key facts
| Recall number (Z-number) | Z-1983-2013 |
|---|---|
| Recall event | 65785 |
| Product | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation… |
| Product code | GEI |
| Recalling firm | Gyrus Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2014 |
| 510(k) numbers | K031080 |
| FEI number | 3011050570 |
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