BEUDAMED
    FDA Recall 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 · Initiated September 12, 2024

    Recall

    Recall Number
    Z-0288-2025
    Event Number
    95462
    Firm
    Iotamotion Inc
    FEI Number
    3030411493
    Product Code
    QQH
    Status
    Completed
    Root Cause
    Process control
    Initiated
    September 12, 2024
    Posted
    November 1, 2024
    Address
    4205 White Bear Pkwy, Ste 600, Vadnais Heights, MN, 55110-7648

    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.

    Action

    The firm did not issue any communication. They distributed the devices and saw through their ERP system that the devices had been used. The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as "distributed."

    Distribution

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

    Quantity

    5 devices