BEUDAMED
    FDA Enforcement Class II Ongoing

    Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

    Recall: Z-2293-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2293-2026
    Event ID
    98804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Kico Knee Innovation Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    April 23, 2026
    Classification Date
    June 2, 2026
    Address
    Suite 3, Building 1, 20 Bridge St, Pymble, N/A, Australia

    Description

    Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

    Reason

    The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

    Code Info

    All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;

    Distribution

    Worldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI, CO, MT, FL, IL, NY, AL, WI, NE, AZ, MN, VT, NH, MD, RI, MA, NJ, PA, KS, WA, ID, OR, TN, VA, PR and the countries of Australia, France, Germany, Italy.

    Quantity

    124 kits