Recall record at a glance
| Official record | Z-1073-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | CryoLife, Inc. |
| Report date | Apr 3, 2019 |
| Recall initiation date | Jan 17, 2019 |
| Quantity | 2 devices |
| Location | Kennesaw, GA, United States |
Official product description
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.
Why the product was recalled
On-X Valve was mislabeled with the incorrect serial number.
Distribution information
Worldwide Distribution - US Nationwide - Georgia and Germany.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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