BEUDAMED
    FDA Recall 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 · Initiated August 4, 2017

    Recall

    Recall Number
    Z-3215-2017
    Event Number
    77891
    Firm
    Ultradent Products, Inc.
    FEI Number
    1718912
    Product Code
    EKN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 4, 2017
    Terminated
    January 4, 2018
    Address
    505 W 10200 S, South Jordan, UT, 84095-3800

    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.

    Action

    The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.

    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