BEUDAMED
    FDA Enforcement Class II Terminated

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    Recall: Z-1360-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1360-2016
    Event ID
    73579
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    January 11, 2016
    Classification Date
    April 8, 2016
    Termination Date
    July 24, 2019
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    Reason

    Potential for a component contained in the Implant System to be non-sterile.

    Code Info

    Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.

    Distribution

    Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.

    Quantity

    117 devices