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Terminated

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

FDA Recall Z-2715-2017 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeLWQ
Date Initiated2015-06-12
Date Terminated2020-08-04
Product Quantity52

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.

Firm Action

On-X LTI Management Team had assessed this event to not be reportable. Correction were done by the On-X LTI in 2015.

Root Cause

Labeling mix-ups

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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