Items added to the Center for Devices and Radiological Health's Consumer website within the last month. http://www.fda.gov/cdrh/consumer/ en-us Mon, 23 Nov 2009 07:17:49 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/consumer/ The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... Wed, 18 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm191091.htm Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device. Thu, 12 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm190300.htm The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. Mon, 09 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189615.htm Reason for Recall: Laboratories are unable to recover patient samples above 200mg/dL that results in inaccurate glucose values above this range. Fri, 06 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189467.htm The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm189301.htm Reason for Recall: The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions... Wed, 04 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188972.htm Reason for Recall: A potential malfunction may cause serious injury or death. Tue, 03 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188795.htm