A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The Chinese Department of Health has issued a voluntary recall for Biomet Microfixation’s Sternalock Blu Implant Tray. The screw measuring area is inaccurate and could cause the incorrect screw to be chosen by the medical professionals. It is possible that the screw could come into contact with the lung, heart muscle or an artery and result in a pneumothorax or bleeding.