Iotamotion Inc is recalling 5 units of the iotaSOFT Plus Drive Unit (Model REF IM-05), which is a surgical tool used to help surgeons place cochlear implants. The recall was issued because the device labels contain an incorrect Global Trade Item Number (GTIN), which could lead to errors in tracking or identifying the medical device. These specific units were distributed only within the state of Iowa.
An incorrect GTIN on a medical device label can lead to logistical confusion or incorrect device identification during surgical preparation, although the manufacturer has classified this specific tracking error as a low-level risk.
Manufacturer notification and correction of labeling information.
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Sources: FDA iRES · Raw API Response
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