BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

    Recall: Z-3055-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3055-2018
    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¿ 11 mm x 180 mm, Item Number: 814311180

    Reason

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

    Code Info

    017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000

    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