BEUDAMED
    FDA Enforcement Class II Terminated

    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

    Recall: Z-0022-2014 · Reported October 23, 2013

    Enforcement

    Recall Number
    Z-0022-2014
    Event ID
    66268
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Harvest Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2013
    Initiation Date
    September 11, 2013
    Classification Date
    October 17, 2013
    Termination Date
    February 10, 2014
    Address
    40 Grissom Rd Ste 100, Plymouth, MA, 02360-7205, United States

    Description

    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

    Reason

    Potential for leur connector to leak or have cracks.

    Code Info

    GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP-10i-0010

    Distribution

    Worldwide Distribution - USA Nationwide: TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, GA, MA, NY, PA, CO, CA and in the countries of Australia, Brazil, China, Singapore, Vietnam, Dominican Republic.

    Quantity

    730 cases (3 kits per case)