FDA recall Z-3108-2017

Product

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

US Distribution to the state of : Illinois

Key facts

Status

Terminated

Initiation date

2014-02-12

Report date

2017-09-13

Termination date

2019-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3108-2017