BEUDAMED
    FDA Recall 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 · Initiated January 18, 2016

    Recall

    Recall Number
    Z-0816-2016
    Event Number
    73164
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    January 18, 2016
    Terminated
    May 25, 2016
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.

    Distribution

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

    Quantity

    8 units