BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0588-04 · Initiated December 19, 2003

    Recall

    Recall Number
    Z-0588-04
    Event Number
    28148
    Firm
    Shelhigh Inc
    FEI Number
    1000081147
    Product Code
    GXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 19, 2003
    Posted
    July 20, 2004
    Terminated
    April 6, 2006
    Address
    650 Liberty Ave, Union, NJ, 07083-8130

    Description

    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.

    Reason

    The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.

    Action

    Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.

    Distribution

    The product is distributed natiowide to 19 different hospitals.

    Quantity

    1002 units