BEUDAMED
    FDA Enforcement Class II Terminated

    K-Wire, 1.35 mm x 170 mm

    Recall: Z-1035-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1035-2022
    Event ID
    89984
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    March 25, 2022
    Classification Date
    May 5, 2022
    Termination Date
    May 15, 2026
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    K-Wire, 1.35 mm x 170 mm

    Reason

    Products do not meet length and diameter specifications.

    Code Info

    Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

    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