BEUDAMED
    FDA Recall Terminated

    Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

    Recall: Z-2199-2008 · Initiated May 9, 2008

    Recall

    Recall Number
    Z-2199-2008
    Event Number
    48677
    Firm
    Biomet 3i, Inc.
    FEI Number
    1038806
    Product Code
    EJB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 9, 2008
    Posted
    September 16, 2008
    Terminated
    January 15, 2009
    Address
    4555 Riverside Drive, Palm Beach Gardens, FL, 33410

    Description

    Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

    Reason

    The drill malfunctions while in use. The drill has been observed to become lodged in the handle.

    Action

    The recall was initiated in 5/9/2008. Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a fax letter. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affect product to Biomet 3I. Replacement handles will be provided. Contact Biomet 3i, at 1-561-776-6906 or x6904 for assistance.

    Distribution

    Worldwide.