The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that […]
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 […]
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 […]
Janssen Pharmaceuticals’ type 2 diabetes medication is under new scrutiny. This new scrutiny follows confirmation from the Food and Drug Administration (FDA) that use of the drug canagliflozin, sold as Invokana and Invokamet, potentially increases the risk of amputation of the feet or legs. Most of these amputations have involved […]
The U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “The Panel”) is a body of seven federal district judges who manage multidistrict litigation, meeting on a bimonthly basis to consider requests to establish MDLs. The Panel has the authority to determine whether civil actions pending in two or more federal […]
After the blood monitoring device INRatio recall, a class-action lawsuit filed against the manufacturer, Alere, has settled out of court. So it is safe to say the global corporation with headquarters in Waltham, Mass., that touts itself as a leader in rapid diagnostics, likely dodged a bullet. Class 1 INRatio […]
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 […]
The Prelude Short Sheath is a medical device used to guide catheters into the body to treat kidney disease, thrombosis and other conditions that require access to arteries and veins. It has recently been recalled by the U.S. Food and Drug Administration. The FDA said Merit Medical’s Prelude Short Sheath could […]
A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need. The U.S. Food and Drug Administration notified the public March 31, 2017 about the recall by Meridian Medical Technologies / […]
In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re: Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, […]
