BEUDAMED
    FDA Enforcement Class II Terminated

    Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

    Recall: Z-1268-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1268-2021
    Event ID
    87443
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CARESTREAM DENTAL, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    February 15, 2021
    Classification Date
    March 17, 2021
    Termination Date
    January 14, 2023
    Address
    3625 Cumberland Blvd Se Ste 700, N/A, Atlanta, GA, 30339-6406, United States

    Description

    Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

    Reason

    The mirror may become detached and fall from the unit

    Code Info

    All lot numbers

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.

    Quantity

    11400 devices