BEUDAMED
    FDA Enforcement Class II Ongoing

    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

    Recall: Z-1935-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1935-2024
    Event ID
    94380
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CORENTEC CO., LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 12, 2024
    Initiation Date
    March 29, 2024
    Classification Date
    May 31, 2024
    Address
    12 Yeongsanhong1-Gil; Seobuk, N/A, Cheonan, N/A, N/A, Korea (the Republic of)

    Description

    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

    Reason

    Due to unsupported 10 year expiration date.

    Code Info

    Lot Code: Model No: 01.10.9XX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.921 LOSPA Patella Component 26mm 0108806373833922172706281000AGEM20 00AGEM20 6/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172711281010AGHP27 10AGHP27 11/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172904281010AJDR25 10AJDR25 4/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172812281010AHL625 10AHL625 12/28/2028 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172907281010AJFR25 10AJFR25 7/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172909281010AJJ528 10ajj528 9/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172505281010AEFC25 10AEFC25 5/28/2025 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172805281010AHCY28 10AHCY28 5/28/2028 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172904281010AJDR28 10AJDR28 4/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172907281010AJH625 10AJH625 7/28/2029 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172503281000AED827 00AED827 3/28/2025 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172603281000AFAM25 00AFAM25 3/28/2026 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172907281000AJDC25 00AJDC25 7/28/2029 Lospa Knee System 01.10.9GC LOSPA Patella Component 40mm 0108806373853708172901281000AJBC25 00AJBC25 1/28/2029

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.

    Quantity

    35