BEUDAMED
    FDA Recall Open, Classified

    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

    Recall: Z-0363-2022 · Initiated November 1, 2021

    Recall

    Recall Number
    Z-0363-2022
    Event Number
    89031
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 1, 2021
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

    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.

    Action

    The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out.

    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

    38 units