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U.S. Department of Health and Human Services

Class 2 Device Recall bileaflet mechanical heart valve

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  Class 2 Device Recall bileaflet mechanical heart valve see related information
Date Initiated by Firm June 12, 2015
Create Date July 12, 2017
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-2715-2017
Recall Event ID 77565
PMA Number P000037 
Product Classification Heart-valve, mechanical - Product Code LWQ
Product On-X Prosthetic Heart Valve

Product Usage:
Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Code Information Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact
770-419-3355
Manufacturer Reason
for Recall		 Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
FDA Determined
Cause 2		 Labeling mix-ups
Action On-X LTI Management Team had assessed this event to not be reportable. Correction were done by the On-X LTI in 2015.
Quantity in Commerce 52
Distribution Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel
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.
PMA Database PMAs with Product Code = LWQ and Original Applicant = On-X Life Technologies, Inc.
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