Z-1073-2019Class II

On-X Aortic Heart Valve with Anatomic Sewing Ring

Name: Z-1073-2019 On-X Aortic Heart Valve with Anatomic Sewing Ring
Creator: CryoLife, Inc.
Published: 2019-01-17
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2019-01-17 / Terminated / root cause: manufacturing process

FDA source

CryoLife, Inc. began a recall of 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... on 2019-01-17. FDA classified it as Class II and gives the reason as "On-X Valve was mislabeled with the incorrect serial number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1073-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-17
Posted: 2019-03-28
Terminated: 2020-06-09
Recalling firm: Artivion, Inc.
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.
Product code: LWQ Heart-Valve, Mechanical
Reason for recall: On-X Valve was mislabeled with the incorrect serial number.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1073-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1073-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code LWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)