BEUDAMED
    FDA Enforcement Class II Ongoing

    Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

    Recall: Z-1494-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1494-2021
    Event ID
    87645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 5, 2021
    Initiation Date
    March 18, 2021
    Classification Date
    April 26, 2021
    Address
    235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, 44223-3701, United States

    Description

    Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

    Reason

    The incorrect dental pins were packaged and subsequently distributed.

    Code Info

    Lot/Batch number: K39841

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.

    Quantity

    65 packs of 20 pins