Device recall
Z-2380-2021: Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2380-2021 |
|---|---|
| Recall event | 88448 |
| Product | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC |
| Product code | GEI |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2023 |
| 510(k) numbers | K081766 |
| FEI number | 2429304 |
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