FDA Safety Communication: Exactech Equinoxe Shoulder System with Defective Packaging

On Jan. 16, the U.S. Food and Drug Administration (FDA) alerted patients and healthcare providers about possible health risks associated with the Equinoxe Shoulder System joint replacement devices. These devices were manufactured by Exactech between 2004 and August 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. 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 communication from the FDA has patient and provider recommendations.

FDA has the full communication.