FDA recall Z-2715-2017

Product

On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

Reason for recall

Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.

Distribution

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel

Key facts

Status

Terminated

Initiation date

2015-06-12

Report date

2017-07-19

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2715-2017