Device recall
Z-0181-2010: Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated…
FDA device recall · Class II · Organogenesis, Inc.
Key facts
| Recall number (Z-number) | Z-0181-2010 |
|---|---|
| Recall event | 53458 |
| Product | Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers. |
| Product code | MGR |
| Recalling firm | Organogenesis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2010 |
| 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