BEUDAMED
    FDA Recall Open, Classified

    K-Wire, 1.35 mm x 170 mm

    Recall: Z-1035-2022 · Initiated March 25, 2022

    Recall

    Recall Number
    Z-1035-2022
    Event Number
    89984
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    LXH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 25, 2022
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    K-Wire, 1.35 mm x 170 mm

    Reason

    Products do not meet length and diameter specifications.

    Action

    The firm sent a recall notification to the consignees on 03/25/2022 via email. The consignees were instructed to discontinue use, sale, and distribution of the product. The consignees were also instructed to contact [email protected] to arrange return of the affected product.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

    Quantity

    300 pieces