BEUDAMED
    FDA Recall Terminated

    Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.

    Recall: Z-1106-2008 · Initiated January 10, 2008

    Recall

    Recall Number
    Z-1106-2008
    Event Number
    46340
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    JDZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 10, 2008
    Posted
    May 1, 2008
    Terminated
    July 31, 2008
    Address
    4100 E. Milham Ave., Portage, MI, 49002-9704

    Description

    Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.

    Reason

    Sterility may be compromised, as the packaging may have channels in the packaging seal.

    Action

    Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.

    Distribution

    Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.

    Quantity

    25 boxes of 6 each