BEUDAMED
    FDA Enforcement Class II Ongoing

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

    Recall: Z-2354-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2354-2024
    Event ID
    94832
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medical Depot Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 24, 2024
    Initiation Date
    June 14, 2024
    Classification Date
    July 12, 2024
    Address
    99 Seaview Blvd Fl 2, Port Washington, NY, 11050-4606, United States

    Description

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

    Reason

    The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury

    Code Info

    UPC: 822383019093 (791BL) All serial numbers beginning with 21S

    Distribution

    Nationwide Foreign: Canada

    Quantity

    875 units