BEUDAMED
    FDA Enforcement Class II Ongoing

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    Recall: Z-1787-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1787-2024
    Event ID
    94332
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ossur H / F
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    March 25, 2024
    Classification Date
    May 10, 2024
    Address
    Grjothals 5, N/A, Reykjavik, N/A, N/A, Iceland

    Description

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    Reason

    Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

    Code Info

    UDI: 05690967598426/ Serial Number: HF377253 1

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.

    Quantity

    N/A