BEUDAMED
    FDA Enforcement Class II Terminated

    High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

    Recall: Z-0818-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0818-2016
    Event ID
    72911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    July 30, 2013
    Classification Date
    February 17, 2016
    Termination Date
    February 24, 2021
    Address
    130 Forbes Blvd, Mansfield, MA, 02048, United States

    Description

    High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

    Reason

    During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.

    Code Info

    50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254

    Distribution

    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.

    Quantity

    203 units