Class III

Medical Device Recall: 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 controllin

Iotamotion Inc · September 12, 2024

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

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

Quantity Affected

5 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0288-2025

Status: completed

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