BEUDAMED
    FDA Recall Terminated

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    Recall: Z-2098-2016 · Initiated April 28, 2016

    Recall

    Recall Number
    Z-2098-2016
    Event Number
    74061
    Firm
    CMP Industries, Llc
    FEI Number
    1315551
    Product Code
    EBI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 28, 2016
    Terminated
    May 25, 2018
    Address
    413 N Pearl St, Albany, NY, 12207-1311

    Description

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    Reason

    Possible presence of foreign material (rust).

    Action

    On April 28, 2016, Nobilium, Division of CMP Industries LLC distributed Urgent Recall notices and Response Forms to their customers via courier service. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their possession subject to recall, please contact the firm by calling John Nicpon at 518-434-3147, ext. 144. Hours of operation are Monday - Friday 8-4:30 pm, EST. Return completed recall response forms to [email protected].

    Distribution

    Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

    Quantity

    77 units Total