BEUDAMED
    FDA Recall Terminated

    EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01

    Recall: Z-2665-2017 · Initiated May 25, 2017

    Recall

    Recall Number
    Z-2665-2017
    Event Number
    77004
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HTX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 25, 2017
    Terminated
    July 26, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01

    Reason

    Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

    Action

    On May 22, 2017 Exactech sent a Notification to all their Direct Accounts an Distributors telling them that a new updated technical techniques LIT # 718-01-30 Rev J is now available in their website (www.exac.com) or can be requested by contacting the Customer Service Representative at 800-392-2832, fax 352-378-2617 or via e-mail at [email protected]. This updated the technical techniques for implantation for Equinoxe Platform Shoulder System to clarify the proper technique for use of the Pilot Tip Reamers, i.e., to include caution statement that the surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head, as this may result in instrument breakage. The notification also request to forward and informed this notice to all the accounts that have received this product and to complete and return the attached Field Advisory Notice Respond Form within 5 days of receipt. For more information please contact: Kaya Davis, Inventory Representative at [email protected] or by phone at (352) 377-1140

    Distribution

    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom

    Quantity

    928