# FDA recall Z-2715-2017

> **CryoLife, Inc.** · Class II · device recall initiated 2015-06-12.

## Product

On-X Prosthetic Heart Valve    Product Usage:  Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

## Reason for recall

Incorrect product label.  The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.

## Distribution

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN.  and the countries of Finland, United Kingdom and Israel

## Key facts

- **Recall number:** Z-2715-2017
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-06-12
- **Report date:** 2017-07-19
- **Termination date:** 2020-08-04

- **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-2715-2017

## Citation

> AI Analytics. FDA recall Z-2715-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2715-2017. Source: US FDA. Licensed CC0.

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