BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

    Recall: Z-3047-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3047-2018
    Event ID
    80755
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2018
    Initiation Date
    July 17, 2018
    Classification Date
    September 13, 2018
    Termination Date
    June 2, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

    Reason

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

    Code Info

    017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090

    Distribution

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

    Quantity

    5947 total