BEUDAMED
    FDA Recall Terminated

    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

    Recall: Z-2644-2017 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2644-2017
    Event Number
    77002
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 22, 2017
    Posted
    June 19, 2017
    Terminated
    July 26, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

    Reason

    The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.

    Action

    Exactech sent an Field Advisory Notice dated May 22, 2017, by mail informing the customers the updated surgical technique is available on Exactech's website (www.exac.com). The notice requested consignees: Extend the information to accounts in possession of the product Complete & return the attached Field Advisory Notice Response Form to Exactech. For further questions, please call (800) 392-2832.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom

    Quantity

    477