BEUDAMED
    FDA Enforcement Class II Ongoing

    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

    Recall: Z-2107-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2107-2021
    Event ID
    88200
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 28, 2021
    Initiation Date
    June 14, 2021
    Classification Date
    July 21, 2021
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

    Reason

    Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

    Code Info

    Lots 12758314 and 13022357

    Distribution

    US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.

    Quantity

    3985 pieces