Product News and Recalls

Zimmer Biomet Recalls Shoulder Device Due to High Fracture Rates

zimmer recalls shoulder implantMedical device manufacturer Zimmer Biomet has recalled its Comprehensive Reverse Shoulder implant. The device was intended for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and had a previously failed shoulder joint replacement.

The Comprehensive Reverse Shoulder is being recalled because the devices are fracturing at a higher rate than is stated in the product’s labeling. Device fractures may result in the need for revision surgeries ...

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Lopez McHugh Releases Statement on H.R. 985

Last night, the House Judiciary Committee voted a bill out of committee that if passed into law, would eviscerate Americans’ abilities to bring nearly every type of mass action currently available to them in the Court system. With the stroke of a pen, this new law would eliminate large groups of individuals’ legal rights to take action against corporate wrongdoing. This includes the enforcement of civil rights; as well as consumer, employee, and investor protections.

The Trump administration has already made ...

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Overused and Easily Forgotten – The Threats of IVC Filters

threats loom large for IVC filter patientsWhen a patient is implanted with an IVC filter, they may not know it but a clock starts. Small, brittle, and with a long history of faults, the risks of injury posed by some filters start to accumulate within days of the implantation. And, perhaps unbeknownst to the patient, the longer the device stays in place, the greater the chance becomes that those risks turn into actual medical issues and ...

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Study Finds Bacteria in Medical Scopes Survives Intensive Cleaning

study finds bateria still present in medical scopes after cleaningInformation continues to come to light about threatening bacteria found in medical scopes used for critical procedures, the LA Times reports. Cleaning requirements for the devices have become increasingly strenuous since 2015. That’s when Olympus, a major manufacturer, disclosed to US medical professionals that their hard-to-clean duodenoscope design retained bacteria – even after going through reprocessing.

The FDA has urged hospitals and other facilities that use duodenoscopes ...

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FDA Cautions Against Excessive Anesthesia for Young Children

fda warns on anesthetics in childrenThe FDA is now requiring 11 anesthetic and sedation drugs to carry additional warnings on their labels because their extended use in young children might lead to brain damage. The warnings will apply to children aged three years and younger, as well as pregnant women in their third trimester.

Concern has slowly grown over using anesthetics during critical periods of brain development. Repeated use, as well as single sessions lasting longer than ...

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FDA Warns on Hyland’s Homeopathic Teething Products

fda urges caution on hyland's teething gelsThe inconsistencies in belladonna levels found in homeopathic teething products continue to put babies at risk.

Late last year, the FDA began investigating inconsistent levels of belladonna – also known as nightshade – in homeopathic remedies for infant teething pain. As a homeopathic remedy, these so called ‘natural’ products are not subject to FDA verification or regulation. They are not tested for safety before being unleashed on an unwitting public and ...

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