BEUDAMED
    FDA Enforcement Class II Terminated

    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

    Recall: Z-0414-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0414-2018
    Event ID
    78903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    August 31, 2017
    Classification Date
    January 26, 2018
    Termination Date
    August 6, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

    Reason

    Potentially mislabeled.

    Code Info

    Catalog #: 314-13-03 Serial Range: 5013050 - 5013079

    Distribution

    Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland

    Quantity

    30