Device recall
Z-0144-2012: Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5"…
FDA device recall · Class II · Davol, Inc., Sub. C. R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0144-2012 |
|---|---|
| Recall event | 60057 |
| Product | Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars. |
| Product code | FTL |
| Recalling firm | Davol, Inc., Sub. C. R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2013 |
| 510(k) numbers | K101928 |
| 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