BEUDAMED
    FDA Enforcement Class II Ongoing

    Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

    Recall: Z-0654-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0654-2021
    Event ID
    86941
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nova Ortho-Med Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    October 7, 2019
    Classification Date
    December 21, 2020
    Address
    1470 Beachey Pl, N/A, Carson, CA, 90746-4002, United States

    Description

    Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

    Reason

    Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.

    Code Info

    Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)

    Distribution

    U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WY O.U.S.: Taiwan

    Quantity

    10898