BEUDAMED
    FDA Recall 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 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-1360-2016
    Event Number
    73579
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2016
    Terminated
    July 24, 2019
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    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.

    Action

    On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information.

    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