New Jersey Stryker LFit V40 Lawsuits Receive Consolidation

On August 29, 2016, Stryker issued a voluntary recall of certain lots of Stryker LFit Anatomic Cobalt Chromium V40 femoral heads, a prosthetic hip replacement device, manufactured before March 2011. This recall included over 40,000 defective hips. Stryker cited to “higher than expected” complaints about the failure of the femoral head to fully lock onto … Continued

Finally – Victims of Stryker’s Latest Recall Receiving Notice

Lawsuits have been filed against Stryker since 2013 alleging that its line of TMZF hip replacement stems are a danger when combined with metal femoral heads. However, patients who have received this potentially dangerous combination of products are just now being notified. Oddly enough, Stryker is not the one doing the notifying. Despite recalling approximately … Continued

Greatbatch Medical Recalls Hip-Replacement Instrument Which Has Potential To Infect Patients

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 in the joint area after … Continued

Zimmer Biomet Recalls Polyethylene and Ceramic Implants in US and Canada

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 devices. This recall was announced … Continued

Zimmer Biomet’s Class One Recall of the Reverse Shoulder Implant

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 rate of fracture due to … Continued

Bacteria Found in Cardiac Patients Linked to Heater-Cooler Machine

Heater-Cooler Machine Spreads Germs in Sterile Areas The medical device sounds well-intended enough: a heater-cooler machine used during heart surgery to control a patient’s body temperature. Doctors employ them in the hundreds of thousands of cardiac procedures they conduct every year in hospitals across the country. Turns out, the LivaNova PLC (formerly Sorin Group Deutschland GmbH) … Continued

Essure Birth Control Urged To Warn Women About Product Risks

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 new guidance addresses hysteroscopically placed … Continued

Pinnacle Bellwether Trial Verdict

There have been a number of noteworthy developments in the national litigation efforts against DePuy and Johnson & Johnson over its failed Pinnacle metal-on-metal hip implants. There are currently more than 8,000 individual lawsuits pending in state and federal courts around the country alleging that the Pinnacle hip devices are defective due to metal wear … Continued

Essure Has Caused 303 Fetal Deaths, Independent Analysis Shows

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 deaths of four women implanted … Continued

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