BEUDAMED
    FDA Recall Terminated

    Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

    Recall: Z-0413-03 · Initiated November 8, 2002

    Recall

    Recall Number
    Z-0413-03
    Event Number
    25082
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1219602
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 8, 2002
    Posted
    January 9, 2003
    Terminated
    April 20, 2005
    Address
    130 Forbes Boulevard, Mansfield, MA, 02048

    Description

    Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725

    Reason

    Potential for non sterility as package tray does not contain aeration holes for ETO processing.

    Action

    Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.

    Distribution

    Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,

    Quantity

    77 units