BEUDAMED
    FDA Enforcement Class II Terminated

    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    Recall: Z-0024-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0024-2020
    Event ID
    83490
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    July 31, 2019
    Classification Date
    October 1, 2019
    Termination Date
    March 24, 2021
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    Reason

    Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.

    Code Info

    All Serial Numbers are affected

    Distribution

    US Nationwide distribution.

    Quantity

    135