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.
- Company
- Cryolife Inc
- Recall Initiated
- February 12, 2014
- Terminated
- November 5, 2019
- Recall Number
- Z-3108-2017
- Quantity
- 5 units
- Firm Location
- Kennesaw, GA
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
Lot / Code Info
Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Root Cause
Other
Action Taken
On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.
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