BEUDAMED
    FDA Enforcement Class II Terminated

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

    Recall: Z-2578-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2578-2021
    Event ID
    88327
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    April 16, 2021
    Classification Date
    September 27, 2021
    Termination Date
    January 18, 2023
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

    Reason

    Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

    Code Info

    All batch codes

    Distribution

    US Nationwide distribution in the states of FL, MI, NY, TX, WI.

    Quantity

    80 units