BEUDAMED
    FDA Recall Open, Classified

    Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

    Recall: Z-1143-2024 · Initiated January 25, 2024

    Recall

    Recall Number
    Z-1143-2024
    Event Number
    93877
    Firm
    Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany
    FEI Number
    3002718942
    Product Code
    EMA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 25, 2024
    Posted
    February 16, 2024

    Description

    Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

    Reason

    Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

    Action

    Voco issued a field safety notice to its consignees on 01/25/2024 via email. The notice explained the problem, risk, and requested the product be returned. Those who have sold the product were directed to notify their customers and collect the affected product. For questions contact Mr. Michael Cyll at [email protected].

    Distribution

    Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.

    Quantity

    1021 units