Z-0288-2025 Class III
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- September 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
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.
Reason for Recall
Incorrect GTIN number.
Distribution Pattern
Distribution was made to Iowa. There was no government/military/foreign distribution.
Code Information
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).