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U.S. Department of Health and Human Services

Class 2 Device Recall SynerGraft CryoValve Pulmonary Valve and Conduit SG

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  Class 2 Device Recall SynerGraft CryoValve Pulmonary Valve and Conduit SG see related information
Date Initiated by Firm February 17, 2011
Date Posted March 04, 2011
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-1560-2011
Recall Event ID 57974
510(K)Number K092021  
Product Classification Heart Valve, more than minimally manipulated allograft - Product Code DXZ
Product Pulmonary Valve & Conduit SG
Used in heart surgery
Code Information Serial No. 9560908 - Model SGPV00
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 2		 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 and Original Applicant = CRYOLIFE, INC.
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