BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2244-2024 · Initiated May 3, 2024

    Recall

    Recall Number
    Z-2244-2024
    Event Number
    94729
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    HRY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 3, 2024
    Posted
    July 1, 2024
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    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.

    Action

    The recalling firm issued the FSN, dated 05/02/2024, via email. The required actions were to: Immediately check inventory and quarantine all subject product(s); COMPLETE AND RETURN the attached FSCA Acknowledgement; Inform MicroPort Orthopedics of any adverse event immediately; Return any affected product to: MicroPort Orthopedics Inc. 1481 Gulf Stream, Arlington, TN 38002. The consignee is to mark all return shipping boxes with RECALL on several sides for better identification and processing.

    Distribution

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

    Quantity

    40 units