BEUDAMED
    FDA Enforcement Class II Terminated

    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

    Recall: Z-2831-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2831-2018
    Event ID
    80558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beekley Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    June 13, 2018
    Classification Date
    August 16, 2018
    Termination Date
    November 13, 2018
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468, United States

    Description

    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

    Reason

    There is a potential for imaging artifact to mimic calcifications on patient's mammograms

    Code Info

    REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

    Quantity

    3,384,024 pieces in total.