BEUDAMED
    FDA Enforcement Class II Terminated

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    Recall: Z-1019-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1019-2019
    Event ID
    82159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AAP Implantate Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 27, 2019
    Initiation Date
    January 11, 2019
    Classification Date
    March 17, 2019
    Termination Date
    May 26, 2022
    Address
    Lorenzweg 5, N/A, Berlin, N/A, N/A, Germany

    Description

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    Reason

    There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.

    Code Info

    Lot Numbers: I011, I012, I013, I014, I015, I016, I017

    Distribution

    Worldwide Distribution - US Nationwide in the state of Texas and country of Germany

    Quantity

    25 units