BEUDAMED
    FDA Recall Terminated

    Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package

    Recall: Z-1043-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1043-04
    Event Number
    29304
    Firm
    Lang Dental Mfg Co, Inc.
    FEI Number
    1417322
    Product Code
    EBI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    July 20, 2004
    Terminated
    September 20, 2004
    Address
    175 Messner Dr, Wheeling, IL, 60090-6433

    Description

    Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package

    Reason

    The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

    Action

    Lang Dental sent recall letters dated 6/7/04 to their direct accounts, informing them of the contamination of the acrylic resin powders with the black particles and requesting the return of any existing inventory of the affected lots of product for replacement. Distributors were requested to sub-recall the products from their accounts. Follow-up letters were sent to the accounts on 6/14/04, clarifying the lot numbers affected to include both the lot number on the box and the lot number on the bottom of the squeeze bottles affected.

    Distribution

    Nationwide

    Quantity

    27 units