BEUDAMED
    FDA Enforcement Class III Terminated

    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

    Recall: Z-0665-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0665-2018
    Event ID
    79064
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    August 3, 2017
    Classification Date
    February 21, 2018
    Termination Date
    August 28, 2018
    Address
    175 Pineview Dr, N/A, Amherst, NY, 14228-2231, United States

    Description

    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

    Reason

    Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

    Code Info

    Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

    Distribution

    US and Canada

    Quantity

    2,153 units