BEUDAMED
    FDA Enforcement Class II Ongoing

    POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

    Recall: Z-2827-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2827-2020
    Event ID
    86099
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew Orthopaedics AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2020
    Initiation Date
    July 22, 2020
    Classification Date
    August 19, 2020
    Address
    Schachenallee 29, N/A, Aarau, N/A, N/A, Switzerland

    Description

    POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

    Reason

    Multiple lots being recalled due to a product design issue

    Code Info

    Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689

    Distribution

    Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA.

    Quantity

    528 unit