BEUDAMED
    FDA Recall Terminated

    2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy, Finland.

    Recall: Z-0674-2011 · Initiated April 14, 2010

    Recall

    Recall Number
    Z-0674-2011
    Event Number
    55861
    Firm
    Stryker Craniomaxillofacial Division
    FEI Number
    3005101424
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2010
    Posted
    December 16, 2010
    Terminated
    June 6, 2012
    Address
    750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482

    Description

    2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy, Finland.

    Reason

    Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.

    Action

    Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned. Stryker can be contacted about this action at 877-534-2464 (option "Regulatory Affairs", reference Product Field Action #2009-445)

    Distribution

    Nationwide Distribution: Throughout the US

    Quantity

    8,631 all products