BEUDAMED
    FDA Enforcement Class II Terminated

    FlipCutter III Drill

    Recall: Z-1542-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1542-2020
    Event ID
    85019
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    January 20, 2020
    Classification Date
    March 20, 2020
    Termination Date
    April 21, 2025
    Address
    Kibbutz Gatton, N/A, Naharia, N/A, N/A, Israel

    Description

    FlipCutter III Drill

    Reason

    There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

    Code Info

    UDI: 10818674021446 Part Number: AR-1204FF Lots: 19E01, 19E02, 19E03, 19E05, 19E10, 19E11, 19F01, 19F02, 19F03, 19F04, 19F05, 19F06, 19F07, 19F08, 19F09, 19F10, 19J15, 19J16, 19J17, 19J18, 19J19, 19J20, 19J21, 19J22, 19J23, 19J24, 19J25, 19J26, 19J28, 19J29, 19K01, 19K02, 19K03, 19K09, 19K11, 19K12, 19M01, 19M09, 19M10, 19M11, 19M12, 19M13, 19M14, 19M15, 19M16, 19M17, 19M18, 19M21, 19M22, 19N02, 19N03, 19N05, 19N06, 19N07, 19N08, 19N09, 19N11, 19N12, 19N13, 19N14, 19P01, 19P02, 19P03, 19P04, 19P05, 19P06, 19P07, 19P08, 19P09, 19P10, 19P11, 19P12, 19P13, 19R01, 19R02, 19R04, 19R05, 19R06, 19R07

    Distribution

    Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.

    Quantity

    6625 units