CryoLife, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3108-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 12, 2014

Date Posted: September 13, 2017

Recall Number: Z-3108-2017

Event ID: 77728

Reason for Recall:

Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

Status: Terminated

Product Quantity: 5 units

Code Information:

Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902

Distribution Pattern:

US Distribution to the state of : Illinois

Voluntary or Mandated:

Voluntary: Firm initiated