BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 29, 2024

    Recall

    Recall Number
    Z-0699-2025
    Event Number
    95672
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    MBH
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    October 29, 2024
    Posted
    December 18, 2024
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    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.

    Action

    On 10/29/24 field safety notices were emailed to customers who were asked to do the following: 1) Check inventory and quarantine all subject product(s) 2) Return affected products 3) Complete and return the acknowledgement form via email to [email protected] For questions or additional information please contact the firm at: +31 20 545 01 00, or [email protected]

    Distribution

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

    Quantity

    32