BEUDAMED
    FDA Enforcement Class II Terminated

    Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

    Recall: Z-0919-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0919-2020
    Event ID
    84594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 5, 2020
    Initiation Date
    December 17, 2019
    Classification Date
    January 30, 2020
    Termination Date
    August 31, 2023
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

    Reason

    There is a potential for blockage of the Hub Attachment Tube.

    Code Info

    Batch/Lot 051838

    Distribution

    Nationwide in US; no distribution OUS.

    Quantity

    47