Device recall
Z-2243-2023: Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated…
FDA device recall · Class II · Davol, Inc.
Key facts
| Recall number (Z-number) | Z-2243-2023 |
|---|---|
| Recall event | 92213 |
| Product | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only) |
| Product code | FTL |
| Recalling firm | Davol, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130968 |
| FEI number | 1213643 |
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