BEUDAMED
    FDA Recall Open, Classified

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    Recall: Z-0976-2024 · Initiated December 21, 2023

    Recall

    Recall Number
    Z-0976-2024
    Event Number
    93810
    Firm
    G & H Wire Company
    FEI Number
    1833132
    Product Code
    ECI
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    December 21, 2023
    Posted
    February 2, 2024
    Address
    2165 Earlywood Dr, Franklin, IN, 46131-8879

    Description

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    Reason

    Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

    Action

    G&H Orthodontics issued Product Recall Notice to customers on 12/21/23 via E-mail and phone call. Letter states reason for recall, health risk and action to take: Required Action for Users: Return product for disposal. Follow-up Actions by G&H: Flexmedics intends to replace products with accurately labeled products. You may reach G&H at 1.800.526.1026 or 1.31 7.346.6655 if you have additional questions. We are open 7 AM - 7PM US Eastern Time weekdays

    Distribution

    Worldwide - US Nationwide distribution in the states of UT, MO, WV, TX, NJ and the countries of Canada, France, Germany, New Zealand, South Africa, Thailand.

    Quantity

    81 pk (100/pk)