BEUDAMED
    FDA Recall Terminated

    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.

    Recall: Z-1928-2013 · Initiated May 29, 2013

    Recall

    Recall Number
    Z-1928-2013
    Event Number
    65370
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    MBL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 29, 2013
    Posted
    August 8, 2013
    Terminated
    March 22, 2016
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.

    Reason

    One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.

    Action

    All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.

    Distribution

    Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.

    Quantity

    53 units