BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0276-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-0276-2023
    Event ID
    91102
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 22, 2023
    Initiation Date
    October 28, 2022
    Classification Date
    November 22, 2022
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    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.

    Code Info

    UDI/DI 0 0192629 08293 9, Lot 1916715

    Distribution

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

    Quantity

    22 units