BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

    Recall: Z-0452-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0452-2019
    Event ID
    81223
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    October 2, 2018
    Classification Date
    November 13, 2018
    Termination Date
    June 2, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

    Reason

    The set screw is not able to advance or reverse from the original position in the nail.

    Code Info

    Lot number 145060 901680 901690

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.

    Quantity

    2,163 in total (expanded)