BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0818-2016 · Initiated July 30, 2013

    Recall

    Recall Number
    Z-0818-2016
    Event Number
    72911
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    FEI Number
    1219602
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 30, 2013
    Terminated
    February 24, 2021
    Address
    130 Forbes Blvd, Mansfield, MA, 02048

    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.

    Action

    Urgent - Product Recall 1st Notification - Urgent R-2013-13 letters, dated July 30, 2013 were sent overnight via Federal Express to customers. The letters identified the affected product, as well as the potential risk involved. Actions to be taken were provided for both hospital and sales representatives. Hospital representatives were asked to inspect their inventory, locate all devices from the list provided, and quarantine them immediately. The Inventory Return Certification Form should be completed and returned, regardless of whether any affected product is on hand or not. Contact the Smith & Nephew Returns Group at 800-343-5717 option 3) or send an e-mail to [email protected]. They will provide instructions for returning affected product and receiving a replacement.

    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