iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochle
Summary
The FDA issued a Class III for iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended t by Iotamotion Inc. Reason: Incorrect GTIN number..
Details
Source
Device Recall
External ID
Z-0288-2025
Action Date
2024-11-13
Status
Completed
Category
device
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.
Lot/Code Info: Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).
Quantity Affected: 5 devices
Reason for Recall
Incorrect GTIN number.
Distribution
Distribution was made to Iowa. There was no government/military/foreign distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-12
Company
Vadnais Heights, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Iotamotion Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Iotamotion Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Iotamotion Inc have FDA actions?
Iotamotion Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0288-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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