BEUDAMED
    FDA Enforcement Class II Terminated

    4205 Journey Rolling Walker Product Usage: used to assist people in walking

    Recall: Z-0304-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0304-2017
    Event ID
    75408
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nova Ortho-Med Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    October 1, 2016
    Classification Date
    October 24, 2016
    Termination Date
    February 6, 2017
    Address
    1470 Beachey Pl, Carson, CA, 90746-4002, United States

    Description

    4205 Journey Rolling Walker Product Usage: used to assist people in walking

    Reason

    Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.

    Code Info

    Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100

    Distribution

    US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX

    Quantity

    1,380 units