We have been investigating Stryker trunnion failure cases since 2012. During our involvement in Stryker Rejuvenate and ABG II stem failures and subsequent recall we began receiving inquiries into Stryker monoblock stem trunnion failures. At first glance it appeared that most of these failures were associated with Stryker TMZF stems […]
Author: Cal Warriner
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 […]
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 […]
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 / […]
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 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 […]
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 […]
