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Terminated

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.

FDA Recall Z-1073-2019 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeLWQ
Date Initiated2019-01-17
Date Terminated2020-06-09
Product Quantity2 devices

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution - US Nationwide - Georgia and Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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