Devices

Exactech Recalls Equinoxe Shoulder Devices

Exactech has recalled its Equinoxe Shoulder System devices packaged in defective bags from facilities’ unused inventory. Earlier this year, FDA alerted patients and healthcare providers about the joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021, the agency said at the time.

“The defective bags used to package the Equinoxe Shoulder System devices were missing one of the oxygen barrier layers that protect the devices from oxidation, a chemical reaction with oxygen that can degrade plastic components over time,” an agency alert says. “Oxidation can lead to faster device wear or failure, and device component cracking or fracture. This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.”

The implants are intended to be used in adults to replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or loss of normal structure and function. They are are also used to improve previously failed shoulder joint replacement devices when adequate bone and soft tissue are present, according to the alert.

It recommends that healthcare providers not implant any Equinoxe Shoulder Systems packaged in the defective bags. Additionally, it does not recommend removing well-functioning Equinoxe Shoulder Systems from patients who do not have any new or worsening pain or symptoms.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome