BEUDAMED
    FDA Enforcement Class II Ongoing

    ESG PK CUTTING FORCEPS, 5MM, 33CM

    Recall: Z-1167-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1167-2024
    Event ID
    93842
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    December 15, 2023
    Classification Date
    February 20, 2024
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    ESG PK CUTTING FORCEPS, 5MM, 33CM

    Reason

    The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

    Code Info

    Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.

    Quantity

    11,123 units