BEUDAMED
    FDA Recall Terminated

    Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.

    Recall: Z-0521-2007 · Initiated December 22, 2006

    Recall

    Recall Number
    Z-0521-2007
    Event Number
    37067
    Firm
    Stryker Leibinger USA
    FEI Number
    3005101424
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2006
    Posted
    February 27, 2007
    Terminated
    June 4, 2008
    Address
    750 Trade Center Way, Ste 200, Portage, MI, 49002-0482

    Description

    Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.

    Reason

    Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.

    Action

    Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions.

    Distribution

    Nationwide.

    Quantity

    26