BEUDAMED
    FDA Enforcement Class II Ongoing

    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

    Recall: Z-1638-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1638-2022
    Event ID
    90678
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    July 15, 2022
    Classification Date
    August 26, 2022
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

    Reason

    Potential for the incorrect screw to be included in the package.

    Code Info

    GUIDID: 04046964989728 Lot Number: 52758014

    Distribution

    GA, TX

    Quantity

    6 units