BEUDAMED
    FDA Recall Open, Classified

    EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

    Recall: Z-0276-2023 · Initiated October 28, 2022

    Recall

    Recall Number
    Z-0276-2023
    Event Number
    91102
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    HRY
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 28, 2022
    Posted
    November 22, 2022
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

    Reason

    One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

    Action

    MicroPort Orthopedics Disseminated Urgent Field Safety Notices to its consignees on October 28, 2022 via email. The notices explained the issue, the risk, and requested the following: "ACTIONS TO BE TAKEN BY THE USER: Our records indicate that you did receive the above referenced product: - Immediately check inventory and quarantine all subject products - COMPLETE AND RETURN the attached FSCA Acknowledgement - Inform MicroPort Orthopedics of any adverse event immediately - Return any affected product to MicroPort Orthopedics, please see your local distributor for details TRANSMISSION OF THIS NOTICE: This notice needs to be passed on to all those who need to be aware within your organization. CONTACT REFERENCE PERSON: For questions or additional information please contact: MicroPort Scientific Coperatief U.A. Phone: +31 20 545 01 00 Email: [email protected]"

    Distribution

    International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

    Quantity

    22 units