BEUDAMED
    FDA Enforcement Class II Terminated

    PremierPro Aluminum Adjustable Walker

    Recall: Z-0487-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0487-2019
    Event ID
    81367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SVS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 28, 2018
    Initiation Date
    October 1, 2018
    Classification Date
    November 20, 2018
    Termination Date
    July 13, 2020
    Address
    14120 Ballantyne Corporate Pl Ste 425, N/A, Charlotte, NC, 28277-2891, United States

    Description

    PremierPro Aluminum Adjustable Walker

    Reason

    This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.

    Code Info

    Model 7803. Lot number:: CJH05041. Serial number: J1805000577-J1805000864

    Distribution

    US distribution to OH, NY,TX, PA

    Quantity

    256 devices