Iotamotion Inc: Device Recall
Recall #Z-0288-2025 · 09/12/2024
Class III: Low Risk
Recall Details
- Recall Number
- Z-0288-2025
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- Iotamotion Inc
- Status
- Completed
- Date Initiated
- 09/12/2024
- Location
- Vadnais Heights, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Reason for Recall
Incorrect GTIN number.
Product 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.
Distribution Pattern
Distribution was made to Iowa. There was no government/military/foreign distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.