BEUDAMED
    FDA Enforcement Class II Completed

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    Recall: Z-2538-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2538-2019
    Event ID
    83596
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 18, 2019
    Initiation Date
    January 15, 2018
    Classification Date
    September 12, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    Reason

    The affected products were inadvertently packaged with an incorrect screw component.

    Code Info

    13KSL0038C

    Distribution

    Foreign countries of; France, Germany, Netherlands, Norway, Switzerland

    Quantity

    12 units