Dive Brief:
- Exactech has recalled its shoulder replacement device after initially declining to voluntarily remove affected products from the market.
- The Food and Drug Administration, which shared details of the recall Friday, posted a safety alert about Equinoxe Shoulder Systems devices in January. At that time, the FDA raised concerns about accelerated device wear or failure due to packaging deficiencies, but Exactech declined to start a recall.
- In March, Exactech told customers it would recall shoulder devices to “eliminate confusion and concern in the market” following the FDA’s safety warning.
Dive Insight:
Exactech began recalling some devices in 2021 after noticing that hip replacement products were wearing out prematurely. The next year, Exactech linked the problem to defective packaging bags that lacked an oxygen barrier layer. The barrier layer protects the device from oxidation. The FDA advised healthcare professionals against implanting Exactech’s knee, ankle and hip devices in March 2023.
This January, the FDA told healthcare professionals that Exactech sold Equinoxe shoulder devices without the barrier layer manufactured between 2004 to 2021. The agency advised surgeons against implanting the devices, but Exactech declined to recall the products. Days later, the FDA sent Exactech a warning letter.
Exactech wrote to customers shortly after receiving the warning letter. The company cited the FDA’s safety notice, outlined the problems with the devices and shared advice on how to monitor patients who have a shoulder system that is part of the recall but functioning well.
“Oxidation can lead to faster device wear or failure, device component cracking or fracture, new or worsening pain, bone loss, and/or swelling in the affected area,” Exactech said in its March letter to customers, adding that these issues may require patients to get revision surgery.
Exactech passed on the FDA’s recommendation for surgeons to consider performing an X-ray for patients if device failure is suspected.
The recall applies to devices made between 2004 and August 2021. Exactech told customers “conforming product is available, and we do not anticipate any disruption in your service as we perform this removal.” The letter lists more than 120,000 devices sold between 2004 and Feb. 15, 2024.
The company also sent a separate recall notice last week that covers Exactech Optetrak Patella, a device used in knee surgeries.