BEUDAMED
    FDA Enforcement Class II Terminated

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    Recall: Z-1380-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1380-2021
    Event ID
    87584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 21, 2021
    Initiation Date
    March 11, 2021
    Classification Date
    April 9, 2021
    Termination Date
    October 29, 2024
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    Reason

    It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

    Code Info

    Part number: AR-13200T-15.0; Lot code:12135408

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

    Quantity

    32 units