BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

    Recall: Z-0157-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0157-2019
    Event ID
    81038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 8, 2018
    Classification Date
    October 17, 2018
    Termination Date
    July 30, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

    Reason

    There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

    Code Info

    Lot Numbers: 201440

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.

    Quantity

    22