Device recall
Z-2239-2011: Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft…
FDA device recall · Class II · Davol, Inc., Sub. C. R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-2239-2011 |
|---|---|
| Recall event | 58685 |
| Product | Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric". |
| Product code | FTL |
| Recalling firm | Davol, Inc., Sub. C. R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2011 |
| 510(k) numbers | K033814 |
| 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