BEUDAMED
    FDA Enforcement Class II Ongoing

    Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist

    Recall: Z-0724-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0724-2019
    Event ID
    81819
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 23, 2019
    Initiation Date
    November 19, 2018
    Classification Date
    January 11, 2019
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945, United States

    Description

    Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist

    Reason

    Potentially lead to anchor breakage during insertion,

    Code Info

    Lots #: 10175216, 1075219, 10199557, and 10199558

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany

    Quantity

    1308 US and 110 OUS