Device recall
Z-0903-2011: PROCEED Surgical Mesh; Product Code PCDG1;:Lot BMG618; Ethicon, Inc. a Johnson…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-0903-2011 |
|---|---|
| Recall event | 57021 |
| Product | PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. |
| Product code | FTL |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K060713 |
| FEI number | 2210968 |
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