Defective Bags
This January, the FDA alerted patients and health care professionals to accelerated device wear or failure due to packaging deficiencies that could lead to possible health risks, but Exactech declined to start a recall until April. The Equinoxe Shoulder Systems were made by Exactech between 2004 and August 2021 and were packaged in defective bags. According to the FDA, the bags used to package the devices are defective because they were missing one of the oxygen barrier layers that protect the devices from oxidation. This chemical reaction can degrade plastic components over time and oxidation can lead to faster device wear or failure, and device component cracking or fracture. Some people experiencing pain or other symptoms from their implanted shoulder have needed replacement surgery.
Shoulder systems are not the only devices packaged in the defective bags. Exactech also recalled its joint replacement devices manufactured between 2004 and August 2021, and recalled in 2021 and 2022: knee, ankle and hip replacements were also associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.
Exactech and the FDA
The FDA in March 2023 advised health care professionals not to implant Exactech’s knee, ankle and hip devices. But after the alert the agency sent to health care professionals in January 2024, Exactech declined to recall its shoulder products. It took a warning letter in March 2024 to get the medical technology company to write its health care customers, citing the FDA’s safety notice, outlining the problems with its devices and sharing advice on how to monitor patients who have a shoulder system that is part of the recall but functioning well.
In its “Dear Surgeon” letter, the company wrote that “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,” adding that surgeons might consider performing an X-ray for patients if device failure is suspected, and these issues may require patients to get revision surgery. And it lists more than 120,000 devices sold between 2004 and Feb. 15, 2024.
Exactech Lawsuit Update
READ MORE DEFECTIVE HIP IMPLANT LEGAL NEWS
If you have a knee or ankle replacement device and have your device serial number, Exactech has an online database for knee and ankle devices that you can search to see if your implant is a part of their recall. And here is more information about hip and shoulder systems.