Device recall
Z-0588-04: EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4…
FDA device recall · Class II · Shelhigh Inc
Key facts
| Recall number (Z-number) | Z-0588-04 |
|---|---|
| Recall event | 28148 |
| Product | EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536. |
| Product code | GXQ |
| Recalling firm | Shelhigh Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2006 |
| FEI number | 1000081147 |
At a glance
- None 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