Refusal Actions by FDA as Recorded in OASIS for Ireland

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Stryker Orthopaedics
    Limericklimerick , IE LK025                    NYK-DO  112-8764947-1/1/1
    87L--OD   858080007889 SIMPLEX BONE CEMENT
                        09-NOV-2007                        REGISTERED