Defective Medical Devices

Almost half a million pacemakers implanted in patients with heart disease have been recalled because of a scary and shocking scenario: The life-saving devices could be tampered with remotely by computer hackers – pacemaker hacking is becoming a possibility. The U.S. Food and Drug Administration released a safety alert in […]

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 […]

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 […]

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 […]