BEUDAMED
    FDA Enforcement Class II Ongoing

    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

    Recall: Z-2244-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2244-2024
    Event ID
    94729
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 10, 2024
    Initiation Date
    May 3, 2024
    Classification Date
    July 1, 2024
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    Description

    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

    Reason

    One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.

    Code Info

    UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR

    Distribution

    International distribution in the country of China. There is no field inventory in the United States for either lot.

    Quantity

    40 units