BEUDAMED
    FDA Recall Terminated

    PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE FR, CE 0123, 2015/04, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation

    Recall: Z-2199-2010 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-2199-2010
    Event Number
    56187
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 28, 2010
    Posted
    August 10, 2010
    Terminated
    January 23, 2012
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE FR, CE 0123, 2015/04, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation

    Reason

    Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

    Action

    All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.

    Distribution

    KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland

    Quantity

    8 units