FDASeptember 12, 2024device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect GTIN number.
What to do
FDA enforcement status: Completed
Brands named
iotamotion
UPCs
00850002960006
Recall history
No related federal recalls on record for this brand yet.
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