| Date Initiated by Firm | September 12, 2024 |
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| Date Posted | November 01, 2024 |
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| Recall Status1 |
Completed |
| Recall Number | Z-0288-2025 |
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| Recall Event ID |
95462 |
| Product Classification |
Powered insertion system for a cochlear implant electrode array - Product Code QQH
|
| 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. |
|---|
| Code Information |
Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label). |
Recalling Firm/
Manufacturer |
Iotamotion Inc
4205 White Bear Pkwy Ste 600
Vadnais Heights MN 55110-7648
|
| For Additional Information Contact | Khamporn Pendergrass
651-447-4177 |
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Manufacturer Reason
for Recall | Incorrect GTIN number. |
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FDA Determined
Cause 2 | Process control |
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| 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 |
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| Distribution | Distribution was made to Iowa. There was no government/military/foreign distribution. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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