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U.S. Department of Health and Human Services

Class 2 Device Recall OnX Aortic Heart Valve

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  Class 2 Device Recall OnX Aortic Heart Valve see related information
Date Initiated by Firm January 17, 2019
Create Date March 28, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-1073-2019
Recall Event ID 82044
PMA Number P000037 
Product Classification Heart-valve, mechanical - Product Code LWQ
Product On-X Aortic Heart Valve with Anatomic Sewing Ring

Product Usage:
The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
Code Information Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
770-419-3355
Manufacturer Reason
for Recall		 On-X Valve was mislabeled with the incorrect serial number.
FDA Determined
Cause 2		 Employee error
Action The affected customer was initially notified via email on 01/16/2019. A follow up notification explaining the reason for recall was provided via email on about 01/24/2019. Instructions included to quarantine and return the affected device.
Quantity in Commerce 2 devices
Distribution Worldwide Distribution - US Nationwide - Georgia and Germany.
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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