BEUDAMED
    FDA Enforcement Class III Terminated

    The UNI-CP System; Model Number: 330230SND.

    Recall: Z-1410-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1410-2017
    Event ID
    76408
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 25, 2017
    Classification Date
    March 4, 2017
    Termination Date
    November 8, 2017
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    The UNI-CP System; Model Number: 330230SND.

    Reason

    The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

    Code Info

    Lot # FEDT

    Distribution

    Nationwide

    Quantity

    39 units