BEUDAMED
    FDA Enforcement Class II Terminated

    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

    Recall: Z-0775-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0775-2018
    Event ID
    79146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    September 13, 2017
    Classification Date
    February 27, 2018
    Termination Date
    April 21, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

    Reason

    Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

    Code Info

    Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

    Distribution

    Distribution includes US Nationwide.

    Quantity

    337 total