FDAFDA · Food and drugs·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 implant insertion.
Published November 13, 2024 · Recall initiated: September 12, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect GTIN number.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Iotamotion Inc
- Distributor
- Distribution was made to Iowa. There was no government/military/foreign distribution.
- Lot
- Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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