BEUDAMED
    FDA Recall Terminated

    PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.

    Recall: Z-1239-2010 · Initiated January 14, 2010

    Recall

    Recall Number
    Z-1239-2010
    Event Number
    54891
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 14, 2010
    Posted
    April 7, 2010
    Terminated
    April 10, 2012
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.

    Reason

    Firm received complaints of Inclination Set Screws fracturing.

    Action

    All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on January 23, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 23, 2009. They were instructed to immediately quarantine the product for return to Stericycle, Inc., 2670 Executive Dr. Suite A Indianapolis, IN 46241. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-6153.

    Distribution

    Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.

    Quantity

    1,597 units