BEUDAMED
    FDA Recall 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

    Recall: Z-2715-2017 · Initiated June 12, 2015

    Recall

    Recall Number
    Z-2715-2017
    Event Number
    77565
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    LWQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 12, 2015
    Terminated
    August 4, 2020
    Address
    1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632

    Description

    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.

    Action

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

    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

    Quantity

    52