BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.

    Recall: Z-1585-2010 · Initiated December 3, 2009

    Recall

    Recall Number
    Z-1585-2010
    Event Number
    54083
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 3, 2009
    Posted
    May 10, 2010
    Terminated
    September 14, 2012
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.

    Reason

    The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

    Action

    Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100.

    Distribution

    Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.

    Quantity

    3056 Duracon Cutting Blocks, total