BEUDAMED
    FDA Recall Terminated

    SX-One MicroKnife

    Recall: Z-1387-2022 · Initiated June 29, 2022

    Recall

    Recall Number
    Z-1387-2022
    Event Number
    90520
    Firm
    SONEX HEALTH LLC
    FEI Number
    3013479847
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 29, 2022
    Terminated
    April 14, 2023
    Address
    950 Blue Gentian Rd, Eagan, MN, 55121-1576

    Description

    SX-One MicroKnife

    Reason

    Potential of dull blade

    Action

    On 06/29/2022, Sonex Health notified consignees of the recall via emailed letter titled, "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory for affected devices, cease use of the devices and remove them from point of use, notify all applicable personnel or recipients if the product was further distributed or transferred, complete and return the provided response form, and arrange for the return of affected devices.

    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