BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1410-2017 · Initiated January 25, 2017

    Recall

    Recall Number
    Z-1410-2017
    Event Number
    76408
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 25, 2017
    Terminated
    November 8, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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.

    Action

    Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.

    Distribution

    Nationwide

    Quantity

    39 units