BEUDAMED
    FDA Recall Terminated

    Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.

    Recall: Z-0035-2008 · Initiated July 9, 2007

    Recall

    Recall Number
    Z-0035-2008
    Event Number
    44827
    Firm
    Heraeus Kulzer Inc., Dental Products Division
    FEI Number
    1821514
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 9, 2007
    Posted
    October 2, 2007
    Terminated
    March 12, 2008
    Address
    4315 S Lafayette Blvd, South Bend, IN, 46614-2517

    Description

    Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.

    Reason

    The material may solidify in the bottle, and thus be rendered unusable.

    Action

    Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.

    Distribution

    Nationwide and Canada.

    Quantity

    1,236