Recall Z-0588-04 ยท GXQ Dura Substitute
Shelhigh Inc
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.
| Date | Jul 20, 2004 (initiated Dec 19, 2003) |
| Status | Terminated |
| Reason | The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile. |
| Root cause | Other |
| Action | Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed. |
| Quantity | 1002 units |
| Distribution | The product is distributed natiowide to 19 different hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.