BEUDAMED
    FDA Enforcement Class II Ongoing

    Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526

    Recall: Z-2579-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2579-2023
    Event ID
    92851
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Keystone Industries
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 20, 2023
    Initiation Date
    July 21, 2023
    Classification Date
    September 12, 2023
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239, United States

    Description

    Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526

    Reason

    A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

    Code Info

    UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.

    Quantity

    337 units