BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0665-2018 · Initiated August 3, 2017

    Recall

    Recall Number
    Z-0665-2018
    Event Number
    79064
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 3, 2017
    Terminated
    August 28, 2018
    Address
    175 Pineview Dr, Amherst, NY, 14228-2231

    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.

    Action

    The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.

    Distribution

    US and Canada

    Quantity

    2,153 units