BEUDAMED
    FDA Enforcement Class II Terminated

    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case

    Recall: Z-2101-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2101-2016
    Event ID
    73918
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Depot Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    February 17, 2016
    Classification Date
    June 30, 2016
    Termination Date
    June 13, 2018
    Address
    99 Seaview Blvd Fl 2, Port Washington, NY, 11050-4606, United States

    Description

    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case

    Reason

    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

    Code Info

    Item #.: 1) 10400-1, 2) 10400-8, 3) 10401-1, 4) 10401-8, 5) 10402-1 & 6) 10402-8

    Distribution

    Nationwide Distribution

    Quantity

    123,125 pairs