Class 2 Device Recall SynerGraft CryoPatch Pulmonary HemiArtery SG

• Date Initiated by Firm: February 17, 2011
• Date Posted: March 04, 2011
• Recall Status: Terminated on April 24, 2012
• Recall Number: Z-1561-2011
• Recall Event ID: 57974
• 510(K)Number: K101866
• Product Classification: Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
• Product: Pulmonary Hemi-Artery SG Used in heart surgery
• Code Information: Serial No. 9528019 - Model SGPH00
• 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: Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
• FDA Determined Cause: Other
• Action: CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.
• Quantity in Commerce: One
• Distribution: Nationwide Distribution including AZ & NV
• 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 = DXZ