BEUDAMED
    FDA Enforcement Class II Ongoing

    EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

    Recall: Z-0699-2025 · Reported December 25, 2024

    Enforcement

    Recall Number
    Z-0699-2025
    Event ID
    95672
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2024
    Initiation Date
    October 29, 2024
    Classification Date
    December 18, 2024
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501, United States

    Description

    EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

    Reason

    Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

    Code Info

    REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.

    Distribution

    OUS: CN, GR, ES, ZA, FR, JP, IT

    Quantity

    32