BEUDAMED
    FDA Enforcement Class II Terminated

    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant

    Recall: Z-1026-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1026-2016
    Event ID
    73308
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    February 12, 2016
    Classification Date
    February 29, 2016
    Termination Date
    May 8, 2017
    Address
    175 Pineview Dr, N/A, Buffalo, NY, 14228-2231, United States

    Description

    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant

    Reason

    Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.

    Code Info

    REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)

    Distribution

    Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.

    Quantity

    Domestic: 406 units