BEUDAMED
    FDA Recall Terminated

    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone

    Recall: Z-2167-2012 · Initiated July 3, 2012

    Recall

    Recall Number
    Z-2167-2012
    Event Number
    62525
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 3, 2012
    Posted
    August 9, 2012
    Terminated
    April 18, 2016
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone

    Reason

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

    Action

    Smith & Nephew sent an Urgent Product Recall 1st Notification letters dated June 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to inspect inventory and quarantine them immediately, complete and return the attached form indicating the Lot# and quantities that need to be returned and contact Smith & Nephew Returns Group at 800-343-5717 (option 3) or email to [email protected]. for instructions for returning affected products and receiving a credit. For questions call 1-508-261-3731.

    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

    2,204 units