Recall Z-0288-2025— Iotamotion Inc
Class III · Completed
Class III FDA medical device recall by Iotamotion Inc, initiated 2024-09-12. FDA's recall record names no specific 510(k) clearance for this event. 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 into a radiographically normal cochlea by controlling the speed of implant insertion.. Reason: Incorrect GTIN number..
- Recalling firm
- Iotamotion Inc
- Classification
- Class III
- Status
- Completed
- Initiated
- 2024-09-12
- Firm location
- Vadnais Heights, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.