BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0919-2020 · Initiated December 17, 2019

    Recall

    Recall Number
    Z-0919-2020
    Event Number
    84594
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 17, 2019
    Terminated
    August 31, 2023
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    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.

    Action

    Consignees were notified via e-mail with recall letter dated 12/17/2019. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.

    Distribution

    Nationwide in US; no distribution OUS.

    Quantity

    47