BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

    Recall: Z-0364-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0364-2022
    Event ID
    89031
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 22, 2021
    Initiation Date
    November 1, 2021
    Classification Date
    December 10, 2021
    Termination Date
    June 15, 2026
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

    Reason

    Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

    Code Info

    Batch Number: 20HM10255, 20HM10256, 20HM10257, UDI

    Distribution

    US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

    Quantity

    35 units