Devices

Alert on Equinoxe Shoulder Implants

FDA is alerting patients and healthcare providers about Exactech’s Equinoxe Shoulder System joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021 and were packaged in defective bags.

“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.

The alert recommends that healthcare providers not implant any Equinoxe Shoulder Systems packaged in 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.

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