Class 2 Device Recall SynerGraft CryoValve

• Date Initiated by Firm: January 07, 2011
• Date Posted: February 11, 2011
• Recall Status: Terminated on November 01, 2011
• Recall Number: Z-1219-2011
• Recall Event ID: 57730
• 510(K)Number: K083106
• Product Classification: Heart-valve, allograft - Product Code MIE
• Product: Pulmonary Valve & Conduit SG Used in heart surgery
• Code Information: Serial Number 9748180
• Recalling Firm/ Manufacturer: CryoLife, Inc.; 1655 Roberts Blvd Nw; Kennesaw GA 30144-3632
• For Additional Information Contact: Bryan Brosseau; 770-419-3355
• Manufacturer Reason for Recall: A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
• FDA Determined Cause: Other
• Action: The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.
• Quantity in Commerce: One
• Distribution: Nationwide distribution: USA state of: MI
• 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 = MIE