Device recall
Z-0273-2009: Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use…
FDA device recall · Class II · Gyrus ACMI Corporation
Key facts
| Recall number (Z-number) | Z-0273-2009 |
|---|---|
| Recall event | 49554 |
| Product | Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment. |
| Product code | GEI |
| Recalling firm | Gyrus ACMI Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K041285 |
| FEI number | 3003790304 |
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