Device recall
Z-1022-2011: PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number…
FDA device recall · Class II · Peak Surgical
Key facts
| Recall number (Z-number) | Z-1022-2011 |
|---|---|
| Recall event | 53014 |
| Product | PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not… |
| Product code | GEI |
| Recalling firm | Peak Surgical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2011 |
| 510(k) numbers | K082786 |
| FEI number | 3007069406 |
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