Z-3108-2017 Class II Terminated
FDA device recall Z-3108-2017 was initiated by CryoLife, Inc. on February 12, 2014 and is designated Class II. Reason for recall: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. The recall status is terminated (terminated November 5, 2019). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2017
- Initiation Date
- February 12, 2014
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product 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 for Recall
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Distribution Pattern
US Distribution to the state of : Illinois
Code Information
Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902