Following closely its recall of its reverse total shoulder implants, Zimmer Biomet recalls plastic and ceramic implant parts that are contaminated with endotoxins. Health Canada classifies the recalled products as posing a Type I Hazard. The FDA has adopted approved standards for the presence of acceptable levels of endotoxins in orthopedic […]
In December 2016 Zimmer issued a Class one recall of its Comprehensive Reverse Shoulder Implant System Humeral Tray. Zimmer received 510(K) clearance to market this device in 2008. According to the FDA’s Recall Database, approximately 300 lots of the shoulder implant are being recalled because of a higher than anticipated […]
Lawsuit No. 4 in the case against Johnson & Johnson and its ovarian-cancer-linked talc product has headed to the courtroom in Missouri. It is the fourth in a series of baby powder lawsuits filed nationally. Defense attorneys will watch it closely to see whether monetary damages are awarded for the fourth […]
Miami Beach was the place to be for mass tort lawyers last week, with two drug and medical device conferences as well as a critical hearing before the Judicial Panel on Multidistrict Litigation (also known as the “JPML”). The Judicial Panel, a group of federal judges that meets every two […]
This Simple Question Can Be Challenging for a Surgeon One of the most challenging decisions a surgeon can make when revising a patient with a Stryker Accolade TMZF stem that has failed due to metal wear disease (corrosion and fretting) is whether to leave a well-ingrown stem in place. This […]
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable report to be updated quarterly. The data currently spans twelve years. Advocacy Groups Find Adverse-Event Reports Helpful for Protecting Consumers Business leaders, […]
The U.S. Food and Drug Administration is concerned that women are not as knowledgeable as they should be about the risks associated with permanent Essure birth control. The agency now recommends a black-box warning for the product along with a new patient checklist. The New FDA Guidance on Essure Birth Control The […]
The fate of diabetic patients who suffered pancreatic or thyroid cancer after ingesting incretin-based therapy drugs is now in the hands of the Ninth Circuit Court of Appeals after the claims were dismissed by the California federal court judge who oversaw the national coordinated litigation. In September of 2016, the […]
Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly nightshade, which it received due to its poisonous nature. Still, the plant has been used medicinally for five centuries. Food & […]
Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration (FDA) has the responsibility to govern the process by which pharmaceutical companies introduce new products and seek approval. Two methods generally […]
