BEUDAMED
    FDA Recall Terminated

    SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures

    Recall: Z-0176-2008 · Initiated July 13, 2007

    Recall

    Recall Number
    Z-0176-2008
    Event Number
    38464
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 13, 2007
    Posted
    November 17, 2007
    Terminated
    June 23, 2009
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures

    Reason

    Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

    Action

    Sales Force Managers were notified of this recall by an Urgent Information Recall Notice Letter, via email, on 7/13/07 and 7/23/07, to visit their Consignees. Letters for the Hospitals (Dear Materials Manager) and Dear Doctors Letters were provided as background by the Sales Force Managers during their visits. If any product remained in inventory, it should be quarantined immediately, and returned to DePuy. Hospitals should be notified immediately not to use the affected device. Replacement stocks will have a check mark on the bottom right front of package to indicate it has passed inspection.

    Distribution

    Nationwide Distribution -- including States of Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Mississippi, New Mexico, North Carolina, Pennsylvania, South Dakota, Texas, Utah and Washington.

    Quantity

    3,530