BEUDAMED
    FDA Enforcement Class II Terminated

    NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    Recall: Z-1287-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1287-2013
    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

    NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    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

    1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376

    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

    1,661 boxes