BEUDAMED
    FDA Enforcement Class III Terminated

    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    Recall: Z-1470-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1470-2020
    Event ID
    84960
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    February 7, 2020
    Classification Date
    March 11, 2020
    Termination Date
    June 10, 2020
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    Reason

    Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.

    Code Info

    Lot # 3388360

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland.

    Quantity

    55