Class 2 Device Recall Graft Delivery System

• Date Initiated by Firm: September 11, 2013
• Date Posted: October 17, 2013
• Recall Status: Terminated on February 10, 2014
• Recall Number: Z-0022-2014
• Recall Event ID: 66268
• 510(K)Number: K043261
• Product Classification: Syringe, piston - Product Code FMF
• Product: 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.
• 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
• FEI Number: 1000117351
• Recalling Firm/ Manufacturer: Harvest Technologies Corporation; 40 Grissom Rd Ste 100; Plymouth MA 02360-7205
• For Additional Information Contact: Michelle Sullivan; 508-732-7500
• Manufacturer Reason for Recall: Potential for leur connector to leak or have cracks.
• FDA Determined Cause: Device Design
• Action: Harvest Technologies sent a notification letter dated September 10, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form to confirm the number of kits received, used, and intending to return. They are asked to return the kits with the form. For questions contact Michelle Sullivan at 508-732-7500.
• Quantity in Commerce: 730 cases (3 kits per case)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = FMF