BEUDAMED
    FDA Enforcement Class II Ongoing

    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710

    Recall: Z-0888-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0888-2024
    Event ID
    93687
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    December 1, 2023
    Classification Date
    January 31, 2024
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710

    Reason

    Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

    Code Info

    GTIN: 07613327050295 Lot Numbers: RLAR, 2P84, EW6V, 90AV, 4JHN, 65A3, 22MP, NNE7, Y373, 58LA, VXAL, 4201, A2AN, 5YP8, X0P9, 9A8T,6LN7, WEL3, NDK3, 25WJ, T2JW, YVWT, 7DR0, DMVL,

    Distribution

    Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

    Quantity

    269 units US; 307 units OUS