# FDA recall Z-1073-2019

> **CryoLife, Inc.** · Class II · device recall initiated 2019-01-17.

## 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.

## Reason for recall

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

## Distribution

Worldwide Distribution - US Nationwide - Georgia and Germany.

## Key facts

- **Recall number:** Z-1073-2019
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-17
- **Report date:** 2019-04-03
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kennesaw, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1073-2019

## Citation

> AI Analytics. FDA recall Z-1073-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1073-2019. Source: US FDA. Licensed CC0.

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