Z-0022-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2013
- Initiation Date
- September 11, 2013
- Termination Date
- February 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 730 cases (3 kits per case)
Product 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 for Recall
Potential for leur connector to leak or have cracks.
Distribution Pattern
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.
Code Information
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