BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base

    Recall: Z-2089-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2089-2016
    Event ID
    73629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CMP Industries, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    March 2, 2016
    Classification Date
    June 29, 2016
    Termination Date
    March 16, 2017
    Address
    413 N Pearl St, Albany, NY, 12207-1311, United States

    Description

    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base

    Reason

    Possible presence of foreign material (rust).

    Code Info

    Lot Number 101113

    Distribution

    Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA

    Quantity

    236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)