Device product
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.
Z-0288-2025
Product summary
- Firm
- Iotamotion Inc
- Event
- Event 95462
- Status
- Completed
- Classification
- Class III
- Quantity
- 5 devices
- Official record key
device-enforcement:Z-0288-2025
Official wording
Reason: Incorrect GTIN number.
Code information: Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Distribution pattern: Distribution was made to Iowa. There was no government/military/foreign distribution.
Derived failure modes
-
Unknown
Incorrect GTIN number.