Device recall
Z-2589-2010: Apligraf is supplied as a living, bi-layered skin substitute. Article Number…
FDA device recall · Class II · Organogenesis, Inc.
Key facts
| Recall number (Z-number) | Z-2589-2010 |
|---|---|
| Recall event | 56543 |
| Product | Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not… |
| Product code | MGR |
| Recalling firm | Organogenesis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2011 |
| PMA numbers | P950032 |
| FEI number | 1000148471 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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