BEUDAMED
    FDA Recall Terminated

    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

    Recall: Z-0376-2014 · Initiated September 23, 2013

    Recall

    Recall Number
    Z-0376-2014
    Event Number
    66359
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    MZW
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 23, 2013
    Posted
    November 21, 2013
    Terminated
    May 27, 2016
    Address
    175 Pineview Dr, Buffalo, NY, 14228-2231

    Description

    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

    Reason

    Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

    Action

    The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.

    Distribution

    US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.

    Quantity

    63 refill packs (50 single use applications per refill)