BEUDAMED
    FDA Recall Terminated

    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.

    Recall: Z-1089-2016 · Initiated November 18, 2013

    Recall

    Recall Number
    Z-1089-2016
    Event Number
    71148
    Firm
    CMP Industries, Llc
    FEI Number
    1315551
    Product Code
    EBI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 18, 2013
    Posted
    March 9, 2016
    Terminated
    May 23, 2018
    Address
    413 N Pearl St, Albany, NY, 12207-1311

    Description

    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.

    Reason

    During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.

    Action

    On November 18, 2013, CMP Customer Service contacted customers by telephone requesting return of the affected product and customers were issued a UPS Call Tag. CMP issued a letter to non-responding customers dated December 9, 2013, requesting return of the product because of the possibility of foreign particles. The letter states, the firm found that one of their processes could deliver a material that would pass their QC tests, but may introduce foreign material into the liquid. A customer service representative will be in contact with customers to arrange the return of the product.

    Distribution

    Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.

    Quantity

    246 units