Device recall
Z-1081-2010: Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed…
FDA device recall · Class II · Integra LifeSciences Corp
Key facts
| Recall number (Z-number) | Z-1081-2010 |
|---|---|
| Recall event | 54253 |
| Product | Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural… |
| Product code | GXQ |
| Recalling firm | Integra LifeSciences Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2010 |
| 510(k) numbers | K043427 |
| FEI number | 1121308 |
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