BEUDAMED
    FDA Enforcement Class III Terminated

    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

    Recall: Z-0732-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0732-2020
    Event ID
    84383
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    AAP Implantate Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2020
    Initiation Date
    January 25, 2019
    Classification Date
    December 21, 2019
    Termination Date
    September 30, 2024
    Address
    Lorenzweg 5, Berlin, N/A, Germany

    Description

    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

    Reason

    Products were distributed with the incorrect instructions for use.

    Code Info

    Lot Code: QS0007

    Distribution

    Texas

    Quantity

    7 units