BEUDAMED
    FDA Enforcement Class II Terminated

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    Recall: Z-1675-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1675-2020
    Event ID
    84716
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AAP Implantate Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 15, 2020
    Initiation Date
    November 28, 2019
    Classification Date
    April 6, 2020
    Termination Date
    March 27, 2025
    Address
    Lorenzweg 5, N/A, Berlin, N/A, N/A, Germany

    Description

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    Reason

    The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

    Code Info

    Lot Numbers: I012, I025, I028

    Distribution

    Worldwide Distribution

    Quantity

    7 units