Z-0288-2025Class III

iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in...

Name: Z-0288-2025 iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in...
Creator: Iotamotion Inc
Published: 2024-09-12
License: https://open.fda.gov/license/

Iotamotion Inc / initiated 2024-09-12 / Completed / root cause: manufacturing process

FDA source

Iotamotion Inc began a recall of 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... on 2024-09-12. FDA classified it as Class III and gives the reason as "Incorrect GTIN number". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0288-2025
Classification: Class III
Status: Completed
Initiated: 2024-09-12
Posted: 2024-11-01
Recalling firm: Iotamotion Inc
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.
Product code: QQH Powered Insertion System For A Cochlear Implant Electrode Array
Reason for recall: Incorrect GTIN number.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm did not issue any communication. They distributed the devices and saw through their ERP system that the devices had been used. The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as "distributed."
Quantity in commerce: 5 devices
Distribution: Distribution was made to Iowa. There was no government/military/foreign distribution.
Product codes and lots: Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0288-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0288-2025	Class III	Completed	Voluntary: Firm initiated	2024-11-13	2024-11-01

Product code QQH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)