iotaSOFT Plus Drive Unit recall
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays…
Why was iotaSOFT Plus Drive Unit recalled?
Incorrect GTIN number.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
- Product
- iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays…
- Recalling firm
- Iotamotion Inc
- Quantity
- 5 devices
- Distribution
- Distribution was made to Iowa. There was no government/military/foreign distribution.
- Recall date
- November 13, 2024
- Classification
- Class III
- Status
- Completed
- Agency
- FDA (device)