BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

    Recall: Z-2165-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2165-2012
    Event ID
    62525
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 3, 2012
    Classification Date
    August 9, 2012
    Termination Date
    April 18, 2016
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031, United States

    Description

    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

    Reason

    Distal part of the anchor may break on insertion into bone during surgery

    Code Info

    Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842:

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    913 units