BEUDAMED
    FDA Enforcement Class II Terminated

    LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.

    Recall: Z-0816-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0816-2016
    Event ID
    73164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 24, 2016
    Initiation Date
    January 18, 2016
    Classification Date
    February 17, 2016
    Termination Date
    May 25, 2016
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.

    Reason

    The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.

    Code Info

    14KM16422

    Distribution

    Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.

    Quantity

    8 units