Device recall
Z-1285-2013: DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-1285-2013 |
|---|---|
| Recall event | 64778 |
| Product | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel… |
| Product code | GXQ |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2015 |
| 510(k) numbers | K072207 |
| FEI number | 1121308 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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