Reported Nov 13, 2024 · Completed
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of…
Iotamotion Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iotamotion Inc · 4205 White Bear Pkwy Ste 600 · Vadnais Heights, MN · 55110-7648
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
- Amount recalled
- 5 devices
Where it was sold
Why it was recalled
Incorrect GTIN number.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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