BEUDAMED
    FDA Enforcement Class II Terminated

    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

    Recall: Z-2497-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2497-2019
    Event ID
    83637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    August 7, 2019
    Classification Date
    September 9, 2019
    Termination Date
    May 12, 2020
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

    Reason

    possibility of the sterility batch being insufficiently sterilized

    Code Info

    Lot # 823B

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    0