Device recall
Z-1175-06: GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO…
FDA device recall · Class II · Gyrus Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1175-06 |
|---|---|
| Recall event | 35477 |
| Product | GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the… |
| Product code | GEI |
| Recalling firm | Gyrus Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2007 |
| 510(k) numbers | K020585 |
| 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