Device recall
Z-0375-2007: Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To…
FDA device recall · Class II · Davol, Inc., Sub. C. R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0375-2007 |
|---|---|
| Recall event | 36922 |
| Product | Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished) |
| Product code | GDW |
| Recalling firm | Davol, Inc., Sub. C. R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2016 |
| 510(k) numbers | K050610 |
| FEI number | 1213643 |
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