Notification of the Phillips Respironics defects was first released in April of 2021, followed by the recall in June.
The company is estimating that as many as 3-4 million devices sold before April of 2021, the majority of which are DreamStation models, may be subject to... read more?
Following the emergence of a range of health complaints, MedTech company Phillips has issued a recall for several Respironics ventilators, including CPAP machines, bi-level positive airway pressure (BiPAP) machines, and mechanical ventilators.
The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who... read more?
Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage... read more?
Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled:
On February 2, 2017, Rexina Mize and her husband Minh Nguyen filed a lawsuit against Mentor Worldwide LLC; Johnson & Johnson; Ethicon, Inc. in the Superior Court of California County of Los Angeles for the following:
Plastic surgeons familiar with breast implants may only detect about 30% of ruptures occurring in breast implants, while an MRI can detect around 80% or more of ruptures or leaks in implants. Symptoms of a leaking implant may include:
Patients with defective MemoryGel Silicone breast implants may experience chronic fatigue, muscle pain or weakness, memory loss or confusion, show symptoms of silicone toxicity and/or other implant-related illness. Your plastic surgeon may want to remove... read more?
Additionally, taper lock failures have been reported with LFIT Anatomic CoCR V40 Femoral heads. The following implants manufactured before 2011 are included:
Hip replacements are one of the most common implant procedures performed in the United States and an estimated 250,000 replacements are performed each year. A hip joint is a type of “ball and socket” joint and a total hip replacement involves replacing both... read more?
A hernia occurs when an organ bulges through weakened tissue or abdominal opening, and it can be caused by a number of different things. These ruptures often develop after surgery, where the tissue is in a weakened state and susceptible to damage. Hernias may occur in the abdomen, upper thigh, groin, and/or... read more?
Surgical mesh is a medical device attached to the weakened tissue, or hernia, to provide support and prevent the organ from continuing to push through the wall.
Three different types of mesh may be used for hernia repair:
Synthetic, which is generally made of polyester and polypropylene.
Manufactured by Ethicon, the Physiomesh product was cleared through the FDA 510(K) approval process in 2010. The FDA 510(K) approval process is used when a product is modeled after a device that has been fully approved by the FDA, and it requires less... read more?
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