BEUDAMED
    FDA Recall Terminated

    Equinoxe Cage, Glenoid, Alpha, Medium 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-0415-2018 · Initiated August 31, 2017

    Recall

    Recall Number
    Z-0415-2018
    Event Number
    78903
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 31, 2017
    Posted
    January 18, 2018
    Terminated
    August 6, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Equinoxe Cage, Glenoid, Alpha, Medium 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.

    Action

    Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.

    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