BEUDAMED
    FDA Enforcement Class II Terminated

    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    Recall: Z-1175-2013 · Reported May 1, 2013

    Enforcement

    Recall Number
    Z-1175-2013
    Event ID
    64706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2013
    Initiation Date
    March 22, 2013
    Classification Date
    April 25, 2013
    Termination Date
    February 24, 2014
    Address
    325 Paramount Drive, Raynham, MA, 02767-5199, United States

    Description

    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    Reason

    The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

    Code Info

    ALL from Jan 1 2010 - Corrected IFU implementation date

    Distribution

    Nationwide Distribution.

    Quantity

    46732