BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360

    Recall: Z-3126-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3126-2018
    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 Right 130¿ 11 mm x 360 mm, Item Number: 814511360

    Reason

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

    Code Info

    107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380

    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