Device recall
Z-1282-2013: Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-1282-2013 |
|---|---|
| Recall event | 64778 |
| Product | Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of… |
| Product code | GXQ |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2015 |
| 510(k) numbers | K982180 |
| 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