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

Code information: Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908

Distribution pattern: 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