Device recall
Z-0935-2009: Bard 3D Max Mesh, Left large, Sterile Pre-formed Knitted Polypropylene Product…
FDA device recall · Class III · Davol, Inc., Sub. C. R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0935-2009 |
|---|---|
| Recall event | 50479 |
| Product | Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531 Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use… |
| Product code | FTL |
| Recalling firm | Davol, Inc., Sub. C. R. Bard, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K792281 |
| 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