BEUDAMED
    FDA Enforcement Class II Terminated

    Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.

    Recall: Z-2218-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2218-2016
    Event ID
    74449
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    June 15, 2016
    Classification Date
    July 18, 2016
    Termination Date
    March 22, 2021
    Address
    130 & 120 Forbes Blvd, N/A, Mansfield, MA, 02048, United States

    Description

    Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.

    Reason

    The device could be subject to breaches of its sterile packaging.

    Code Info

    Batch numbers: 50412843, 50477278, 50527184

    Distribution

    Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.

    Quantity

    563