Recall Z-1073-2019 ยท LWQ Heart-Valve, Mechanical
CryoLife, Inc.
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. A
| Date | Jan 17, 2019 |
| Status | Terminated |
| Reason | On-X Valve was mislabeled with the incorrect serial number. |
| Root cause | Employee error |
| Action | The affected customer was initially notified via email on 01/16/2019. A follow up notification explaining the reason for recall was provided via email on about 01/24/2019. Instructions included to quarantine and return the affected device. |
| Quantity | 2 devices |
| Distribution | Worldwide Distribution - US Nationwide - Georgia and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.