BEUDAMED
    FDA Recall 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 · Initiated March 11, 2021

    Recall

    Recall Number
    Z-1380-2021
    Event Number
    87584
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 11, 2021
    Terminated
    October 29, 2024
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    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.

    Action

    A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (LATAM and APAC): Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. The consignee is not required to notify patients of the product recall. Direct customers (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or [email protected]. The consignee is not required to notify patients of the product recall.

    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