BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2107-2021 · Initiated June 14, 2021

    Recall

    Recall Number
    Z-2107-2021
    Event Number
    88200
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    MAI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 14, 2021
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    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.

    Action

    On June 14, 2021 the firm e-mail their consignees with the following instructions: Immediately discontinue use, sale, and distribution of the affected lots of product. and to contact the Field Logistics Services at [email protected] to answer questions regarding credit for affected devices in your possession.

    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