Device recall
Z-1237-2018: Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia"…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1237-2018 |
|---|---|
| Recall event | 79483 |
| Product | Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and… |
| Product code | GDW |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2020 |
| 510(k) numbers | K160176 |
| FEI number | 1219930 |
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