Vadnais Heights, MN, United States
Iotamotion Inc recalls
1 recall recorded since 2018, most recently on 12 September 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class III Medical devices
- Recall started
- 12 September 2024
- Reason
- Incorrect GTIN number.
- Distribution
- Distribution was made to Iowa. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0288-2025
- 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 impla
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.