BEUDAMED
    FDA Enforcement Class II Terminated

    Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.

    Recall: Z-1971-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1971-2021
    Event ID
    87999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spes Medica
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 8, 2021
    Classification Date
    June 25, 2021
    Termination Date
    May 10, 2022
    Address
    Via Buccari 21, N/A, Genoa, N/A, N/A, Italy

    Description

    Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.

    Reason

    The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

    Code Info

    Lot SI20F2956I

    Distribution

    Distribution in the following US states: CA, MA, and SC.

    Quantity

    3 boxes