BEUDAMED
    FDA Enforcement Class II Terminated

    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

    Recall: Z-1003-2015 · Reported January 28, 2015

    Enforcement

    Recall Number
    Z-1003-2015
    Event ID
    70136
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dick's Sporting Goods
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2015
    Initiation Date
    December 29, 2014
    Classification Date
    January 20, 2015
    Termination Date
    September 2, 2015
    Address
    345 Court St, N/A, Coraopolis, PA, 15108-3817, United States

    Description

    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

    Reason

    Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from product labels and advertising.

    Code Info

    Style STE00059FG and Style STE00118FG

    Distribution

    Nationwide.

    Quantity

    32581