Iotamotion Inc recalls iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochle

Recalled November 13, 2024 · FDA recall Z-0288-2025 · Iotamotion

Hazard

Incorrect GTIN number. · FDA Class III

Units

5 devices

Sold at

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

Description

Incorrect GTIN number.

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.

Manufacturer(s)

Iotamotion Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →