BEUDAMED
    FDA Recall Terminated

    AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device.

    Recall: Z-0417-2010 · Initiated September 3, 2009

    Recall

    Recall Number
    Z-0417-2010
    Event Number
    53299
    Firm
    Smith & Nephew, Inc., Endoscopy Div.
    FEI Number
    1219602
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 3, 2009
    Posted
    November 24, 2009
    Terminated
    May 8, 2012
    Address
    130 Forbes Blvd, Mansfield, MA, 02048

    Description

    AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device.

    Reason

    Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

    Action

    A notification letter was issued via Fedex on September 3, 2009 to domestic consignees and international consignees were notified via e-mail. The letter described the issue as the affected device may have improper laser marking. The 4mm devices are marked as 6mm and the 6mm devices are marked at 4mm. Customers were instructed to return the completed response form and affected product in inventory to Smith & Nephew. Direct questions about the recall to your local Smith & Nephew Sales Representatives or call 1-508-261-3655.

    Distribution

    Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.