Defective Medical Devices

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices.

In April of 2017, multi-district litigation (known as “MDL 2775”) was established in federal court in Baltimore, Maryland before United States District Court Judge Catherine C. Blake against Smith & Nephew, which is based in England and sells its products, which are not limited to hip implants, in 90 countries […]

The JPML consolidated 3M Combat Arms Earplugs Lawsuits on April 3, 2019. The 3M Dual-Ended Combat Arms Earplugs may have cause hearing loss in military service members who used them.

On March 28, 2019, the United States Judicial Panel on Multidistrict Litigation will hear arguments from attorneys representing individual service members across the country and attorneys from 3M Company regarding whether claims against 3M for hearing loss injuries stemming from use of the earplugs during active duty should be consolidated […]

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 […]