On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The… — Class II medical device recall Z-1073-2019
Terminated recall by CryoLife, Inc., reported 2019-04-03, distributed nationwide. On-X Valve was mislabeled with the incorrect serial number.
| Recall number | Z-1073-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2019-01-17 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 2 devices |
| Reason classes | labeling |
| Lot numbers | 6827216 |
| Expiration dates | 2024-11-19 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1073-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.