Iotamotion Inc recalls iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion
Recalled 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.
Hazard / Issue
Incorrect GTIN number.
Issued by
FDA
Distribution: Distribution was made to Iowa. There was no government/military/foreign distribution.
Lot/Code Info: Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
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