BEUDAMED
    FDA Recall Terminated

    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.

    Recall: Z-0581-2014 · Initiated November 25, 2013

    Recall

    Recall Number
    Z-0581-2014
    Event Number
    67042
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2013
    Posted
    December 26, 2013
    Terminated
    February 1, 2017
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.

    Reason

    One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

    Action

    All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall.

    Distribution

    Distributed in China and Spain.

    Quantity

    38 units