FDA Enforcement
Class II
Terminated
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.
Recall: Z-3108-2017
·
Reported September 13, 2017
Enforcement
- Recall Number
- Z-3108-2017
- Event ID
- 77728
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CryoLife, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 13, 2017
- Initiation Date
- February 12, 2014
- Classification Date
- September 6, 2017
- Termination Date
- November 5, 2019
- Address
- 1655 Roberts Blvd NW, N/A, Kennesaw, GA, 30144-3632, United States
Description
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
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Code Info
Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Distribution
US Distribution to the state of : Illinois
Quantity
5 units