BEUDAMED
    FDA Enforcement Class II Terminated

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Recall: Z-1429-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1429-2022
    Event ID
    90526
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    November 18, 2020
    Classification Date
    July 21, 2022
    Termination Date
    December 23, 2024
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Reason

    Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

    Code Info

    UDI-DI: 04046964719622

    Distribution

    United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.

    Quantity

    17