BEUDAMED
    FDA Enforcement Class III Terminated

    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

    Recall: Z-0667-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0667-2018
    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 210/A3, Product code 541503AN, Catalog number 541503

    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: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021

    Distribution

    US and Canada

    Quantity

    1,244 units