BEUDAMED
    FDA Enforcement Class II Ongoing

    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

    Recall: Z-2518-2023 · Reported September 13, 2023

    Enforcement

    Recall Number
    Z-2518-2023
    Event ID
    92813
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 13, 2023
    Initiation Date
    July 20, 2023
    Classification Date
    September 6, 2023
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

    Reason

    Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

    Code Info

    UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450

    Distribution

    US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

    Quantity

    25 units