BEUDAMED
    FDA Enforcement Class II Ongoing

    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

    Recall: Z-0910-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0910-2024
    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

    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

    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: 04546540306203 Lot Numbers: 36272501,42380501 42771601

    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.