BEUDAMED
    FDA Recall Terminated

    Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

    Recall: Z-2044-2017 · Initiated March 24, 2017

    Recall

    Recall Number
    Z-2044-2017
    Event Number
    76986
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    MAI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2017
    Terminated
    November 4, 2019
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

    Reason

    Some eyelets broke from SwiveLock Anchor on insertion.

    Action

    On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact [email protected] 866-267-9138

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)