BEUDAMED
    FDA Enforcement Class II Terminated

    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 sizes..

    Recall: Z-1282-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1282-2013
    Event ID
    64778
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    March 28, 2013
    Classification Date
    May 10, 2013
    Termination Date
    June 3, 2015
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339, United States

    Description

    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 sizes..

    Reason

    Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

    Code Info

    1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

    Quantity

    15,607 boxes