Exactech Recalls Shoulder Devices

August 5, 2024, 9:15AM. By Jane Mundy

Exactech finally recalls shoulder devices after FDA sent the medical device maker a warning letter.

Santa Clara, CAExactech has voluntarily recalled ankle, hip, and knee replacement devices over the years but it took an FDA warning letter for the medical device manufacturer to recall its Equinoxe Shoulder Systems. The agency was concerned about the shoulder device failure due to defective packaging and advised surgeons against implanting them.

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

As of June 12, 2024, 2,268 Exactech lawsuits have been filed in state and federal courts. As of July 2024, 1,580 lawsuits were pending in multidistrict litigation before the U.S. District Court, Eastern District of New York. So far, there have been no trials or approved settlements in MDL 3044. To date no court-approved Exactech lawsuits have reached a settlement. Bellwether trials typically determine potential settlement amounts and the first bellwether trial is slated for June 2025.

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.