BEUDAMED
    FDA Enforcement Class II 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 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0581-2014
    Event ID
    67042
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2014
    Initiation Date
    November 25, 2013
    Classification Date
    December 26, 2013
    Termination Date
    February 1, 2017
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    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.

    Code Info

    Batch No. 12BM04836

    Distribution

    Distributed in China and Spain.

    Quantity

    38 units