BEUDAMED
    FDA Recall Terminated

    Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. The device is indicated for use to control bleeding from the bone surface during surgical procedures.

    Recall: Z-0992-2009 · Initiated October 28, 2008

    Recall

    Recall Number
    Z-0992-2009
    Event Number
    50132
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    MTJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 28, 2008
    Posted
    March 4, 2009
    Terminated
    April 29, 2009
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. The device is indicated for use to control bleeding from the bone surface during surgical procedures.

    Reason

    A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. Upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. Further checks determined that two other boxes were missing.

    Action

    Letters were sent via UPS next day air on October 28, 2008 to all customers who purchased finished product codes W31G and DW31B (on inner box labels) from January 1, 2008 through October 22, 2008.

    Distribution

    Nationwide Distribution.

    Quantity

    2,200 foil pouches