BEUDAMED
    FDA Enforcement Class III Completed

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    Recall: Z-0288-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0288-2025
    Event ID
    95462
    Classification
    Class III
    Status
    Completed
    Product Type
    Devices
    Firm
    Iotamotion Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 13, 2024
    Initiation Date
    September 12, 2024
    Classification Date
    November 1, 2024
    Address
    4205 White Bear Pkwy Ste 600, N/A, Vadnais Heights, MN, 55110-7648, United States

    Description

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    Reason

    Incorrect GTIN number.

    Code Info

    Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).

    Distribution

    Distribution was made to Iowa. There was no government/military/foreign distribution.

    Quantity

    5 devices