BEUDAMED
    FDA Enforcement Class II Terminated

    SX-One MicroKnife

    Recall: Z-1387-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1387-2022
    Event ID
    90520
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SONEX HEALTH LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 27, 2022
    Initiation Date
    June 29, 2022
    Classification Date
    July 15, 2022
    Termination Date
    April 14, 2023
    Address
    950 Blue Gentian Rd, N/A, Eagan, MN, 55121-1576, United States

    Description

    SX-One MicroKnife

    Reason

    Potential of dull blade

    Code Info

    Part Number 600112-001; UDI-DI: 00860002094700; Lot Codes: 20013120, 20022821, 20022822, 20022823, 20022824, 20022825, 20070603, 20070604, 20080435, 20080436, 20083114, 20083115, 40051, 40052, 40472, 40473, 40892, 40893, 41460, 41584, 41585.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, KS, MD, MI, MN, MT, NE, NJ, NV, NY, OH, OK, OR, PA, TX, UT, VA, WI, WV, WY.

    Quantity

    3,752 devices