The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests. Greatbatch Medical Recalls The Affected Instrument Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls […]
Category: Defective Medical Devices
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 […]
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 […]
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 […]
A gross discrepancy in the number of fetal deaths attributed to the birth control device Essure has prompted the U.S. Food and Drug Administration to analyze the data and decide whether to change the way the product is marketed. The agency has reported five fetal deaths – along with the […]
Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant. According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine. “It’s the […]
The Uphold Vaginal Support System is a transvaginal mesh product used to treat pelvic organ prolapse (“POP”). Marta Carlson sued Boston Scientific Corporation (“Boston Scientific”), the maker of the Uphold Vaginal Support System, and asserted that the device caused her to suffer chronic vaginal pain, difficulty during intercourse and incontinence. […]
A medical device created by Brainlab and marketed as easy-to-use, intuitive, precise and tailored to surgeons’ needs has been recalled by the U.S. Food and Drug Administration. Cranial-navigation systems sold by Brainlab, a German manufacturer that develops software-based applications for brain surgeons in addition to surgeons in other disciplines such […]
At this time, pending in the federal court MDL proceedings in Georgia and 700 cases pending in the California state court consolidated proceedings. There are also more than 800 individual cases pending on a tolling agreement with Wright Medical, which is a contract that suspends the statute of limitations period […]
