Device recall
Z-1523-2018: Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made…
FDA device recall · Class II · Sofradim Production
Key facts
| Recall number (Z-number) | Z-1523-2018 |
|---|---|
| Recall event | 79662 |
| Product | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material. |
| Product code | FTL |
| Recalling firm | Sofradim Production |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K150091 |
| FEI number | 3003521774 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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