BEUDAMED
    FDA Recall Terminated

    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    Recall: Z-0292-2019 · Initiated September 12, 2018

    Recall

    Recall Number
    Z-0292-2019
    Event Number
    81206
    Firm
    CMP Industries, Llc
    FEI Number
    1315551
    Product Code
    EBI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 12, 2018
    Terminated
    May 19, 2020
    Address
    413 N Pearl St, Albany, NY, 12207-1311

    Description

    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    Reason

    Foreign material in product

    Action

    Nobilium, A Division of CMP Industries LLC notified customer by phone and certified mail on 9/12/18 advising users of the problem and to return product.. Distributors requested to notify the user level (dental laboratory who processed this material. Questions, call 518-434-3147, extension 144, M-F 8-4:30pm (Eastern).

    Distribution

    Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.

    Quantity

    400 units