iotaSOFT Plus Drive Unit…

Date

Nov. 13, 2024

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Completed

Filed by

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.

Reason

Incorrect GTIN number.

Distribution pattern

Distribution was made to Iowa. There was no government/military/foreign distribution.

Quantity

5 devices

Codes and lots

Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).

Recall started

Sept. 12, 2024

Device type

Powered Insertion System For A Cochlear Implant Electrode Array

Root cause (FDA)

Process control

What the company told customers

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."

Recall number

Z-0288-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0288-2025. The agency record governs; check it and the company before acting.