BEUDAMED
    FDA Recall Terminated

    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.

    Recall: Z-0704-2017 · Initiated November 17, 2016

    Recall

    Recall Number
    Z-0704-2017
    Event Number
    75796
    Firm
    Ultradent Products, Inc.
    FEI Number
    1718912
    Product Code
    EBC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 17, 2016
    Posted
    December 3, 2016
    Terminated
    June 5, 2017
    Address
    505 W 10200 S, South Jordan, UT, 84095-3800

    Description

    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.

    Reason

    There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.

    Action

    Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    31