BEUDAMED
    FDA Recall 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 · Initiated February 15, 2021

    Recall

    Recall Number
    Z-1268-2021
    Event Number
    87443
    Firm
    CARESTREAM DENTAL, LLC
    FEI Number
    3002522649
    Product Code
    NOF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 15, 2021
    Terminated
    January 14, 2023
    Address
    3625 Cumberland Blvd Se, Ste 700, Atlanta, GA, 30339-6406

    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

    Action

    The firm initiated the recall by letter on 02/2/2021. The letter explained the problem, requested the consignee cease use of the product and return all affected product.

    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