# FDA recall Z-3108-2017

> **CryoLife, Inc.** · Class II · device recall initiated 2014-02-12.

## Product

On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use.    Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

## Reason for recall

Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

## Distribution

US Distribution to the state of : Illinois

## Key facts

- **Recall number:** Z-3108-2017
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-02-12
- **Report date:** 2017-09-13
- **Termination date:** 2019-11-05

- **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-3108-2017

## Citation

> AI Analytics. FDA recall Z-3108-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3108-2017. Source: US FDA. Licensed CC0.

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