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Recall Observatory FDA recall evidence

Device 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.

Z-1073-2019

January 17, 2019

Class II

Product summary

Firm
CryoLife, Inc.
Event
Event 82044
Status
Terminated
Classification
Class II
Quantity
2 devices
Official record key
device-enforcement:Z-1073-2019

Official wording

Reason: On-X Valve was mislabeled with the incorrect serial number.

Code information: Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024

Distribution pattern: Worldwide Distribution - US Nationwide - Georgia and Germany.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled