Device recall
Z-0452-2011: DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0452-2011 |
|---|---|
| Recall event | 56912 |
| Product | DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter. |
| Product code | GXQ |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2012 |
| 510(k) numbers | K072207 |
| FEI number | 3003418325 |
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