- The Food and Drug Administration issued an alert for patients and healthcare providers about the risks associated with an Exactech shoulder replacement device after the company “declined to initiate a voluntary recall.”
- FDA officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags because of a risk of oxidation that can accelerate device wear or failure. The issue could lead to patients needing additional surgery to replace or correct devices.
- Exactech recalled other orthopedic devices in 2021 and 2022, initially because of excessive and premature wear of unknown cause, and later because it found a problem with its packaging.
In March 2023, the FDA sent a safety communication about risks with Exactech joint replacement devices sold in defective packaging. The packaging of the knee, ankle and hip devices lacked one of the oxygen barrier layers that protect the contents from oxidation. In the absence of the layer, oxygen could react with the devices, causing plastics to degrade and accelerating the wear and failure of the products.
At the time, the agency said it was “working with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks.” Now, the FDA has warned Exactech packaged shoulder systems in defective bags between 2004 and August 2021.
The FDA’s earlier notice about knee, ankle and hip devices followed voluntary recalls by Exactech.
Medical device companies typically voluntarily initiate product recalls, coordinating with the FDA. However, the agency can issue mandatory recall orders if a manufacturer fails to act voluntarily when a device is a risk to health. It is rare for medical device companies to decline to initiate voluntary recalls. Guangdong Haiou Medical Apparatus took that step in 2021, prompting the FDA to advise against using certain syringes and needles, but ultimately began a recall the following year.
The agency is working with Exactech to “evaluate the risks of all joint devices that contain plastic components packaged in defective packaging and review information they provide regarding their joint replacement devices' safety and effectiveness.” Officials are also working with their peers at overseas regulatory agencies to review data on the devices and explore potential causes of the failure rates.