BEUDAMED
    FDA Recall Terminated

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    Recall: Z-1164-2021 · Initiated January 21, 2021

    Recall

    Recall Number
    Z-1164-2021
    Event Number
    87248
    Firm
    G & H Wire Company
    FEI Number
    1833132
    Product Code
    ECI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 21, 2021
    Terminated
    September 20, 2021
    Address
    2165 Earlywood Dr, Franklin, IN, 46131-8879

    Description

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    Reason

    The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.

    Action

    On 1/21/2021, G&H Orthodontics issued a Product Recall Notice to customers via email notifying affected users of a voluntary recall for FlexMedics Patient Elastic Packs. A labelling change that resulted in the color scheme of the FlexMedics Patient Packs product to be updated which was not intended and could result in consumer confusion and/or patient discomfort.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, France, Czech Republic, Greece, Poland, Thailand, Belgium, Denmark, United Kingdom, Canada.

    Quantity

    371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)