BEUDAMED
    FDA Enforcement Class II Terminated

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    Recall: Z-0213-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0213-2016
    Event ID
    72290
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar A. G.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 11, 2015
    Initiation Date
    October 7, 2015
    Classification Date
    November 4, 2015
    Termination Date
    June 14, 2016
    Address
    Fl-9494, N/A, Schaan, N/A, N/A, Liechtenstein

    Description

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    Reason

    A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

    Code Info

    Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017

    Distribution

    Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.

    Quantity

    Domestic: 337 units