BEUDAMED
    FDA Enforcement Class II Terminated

    Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

    Recall: Z-2046-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2046-2017
    Event ID
    76986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    March 24, 2017
    Classification Date
    May 5, 2017
    Termination Date
    November 4, 2019
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

    Reason

    Some eyelets broke from SwiveLock Anchor on insertion.

    Code Info

    Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)

    Quantity

    N/A