According to FierceMedicalDevices, the U.S. Food and Drug Administration (FDA) has issued a warning letter to medical device manufacturer Smith & Nephew over quality-control violations at the company’s facility in Andover, MA. The letter outlines problems related to some of Smith & Nephew’s mechanical morcellators, which are used in surgeries to remove intrauterine tissue. FierceMedicalDevices reports that among the violations mentioned in the FDA’s letter is ...
continue reading...Smith & Nephew Receives FDA Warning Letter
Posted June 8, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls