BEUDAMED
    FDA Enforcement Class II Terminated

    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.

    Recall: Z-3215-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3215-2017
    Event ID
    77891
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2017
    Initiation Date
    August 4, 2017
    Classification Date
    September 26, 2017
    Termination Date
    January 4, 2018
    Address
    505 W 10200 S, N/A, South Jordan, UT, 84095-3800, United States

    Description

    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.

    Reason

    The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Code Info

    Lot numbers BD96Z, BDTDM, and BDTQ6

    Distribution

    Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.

    Quantity

    95 units