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Completed

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.

FDA Recall Z-0288-2025 · Posted 2024-11-01

Recalling FirmIotamotion Inc
Recall StatusCompleted
Product CodeQQH
Date Initiated2024-09-12
Product Quantity5 devices

Reason for Recall

Incorrect GTIN number.

Firm Action

The firm did not issue any communication. They distributed the devices and saw through their ERP system that the devices had been used. The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as "distributed."

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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