Exactech Replacements

Exactech manufactures ankle, knee, hip and shoulder replacement devices. Research shows many of Exactech’s medical devices have a high success rate. However, the company recently recalled several of its joint replacement devices.

In January 2024, the U.S. Food and Drug Administration (FDA) alerted patients and health care providers about risks with Exactech’s Equinoxe Shoulder System. In April 2024, Exactech initiated a voluntary recall of its Equinoxe reverse total shoulder (rTSA) and anatomic total shoulder (aTSA) devices.

The recall applied to devices packaged in defective bags that could affect their safety or effectiveness. According to an Exactech statement, this recall was implemented to “eliminate confusion and concern in the market” and to comply with the FDA’s recommendations regarding removing these devices.

Since August 2021, Exactech has recalled more than 650,000 ankle, knee, shoulder and hip models for issues that led to early device failure. Some people who developed complications from recalled devices have needed revision surgery to fix problems like implant loosening.

Some people who needed revision surgery after receiving implants that were subject to recall have filed lawsuits against Exactech. In October 2022, the Judicial Panel on Multidistrict Litigation consolidated at least 75 Exactach lawsuits. As of March 2025, 1,840 Exactech lawsuits were pending in the MDL.

Exactech knee replacements are medical devices surgeons use to replace arthritic or injured knees. Models include Truliant and Optetrak. According to Exactech, their 10-year success rate is 94–98%.

Exactech initiated a recall in August 2021 for all its ultra-high molecular weight polyethylene inserts in knee replacements. The inserts serve as a replacement for cartilage between the artificial joints.

The company packaged the devices with nonconforming bags that enabled increased oxygen exposure on the insert. According to Exactech’s 2022 updated recall letter, this can contribute to degradation and early implant failure.

Implant degradation leading to excessive wear and possible failure may require revision surgery. Revision surgery for defective Exactech knee replacements typically takes longer than the original replacement surgery and may not be as effective as the initial operation. It also means facing a painful recovery process again, which typically includes physical therapy.

Exactech’s ankle replacements are medical devices surgeons use to replace arthritic or injured ankles. The company’s primary ankle products include the Vantage Total Ankle System and Vantage PSI. Exactech designs these devices to resemble a person’s natural anatomical structure. A 2022 study of the Vantage ankle system in Foot & Ankle Orthopaedics reported a 95.3% success rate.

Exactech issued a recall in August 2021 for the polyethylene liner used in its ankle replacements. The recalled liner mimics cartilage in the ankle and fits between the talar and tibial components. The recall also stems from faulty packaging that allowed for increased oxygen exposure and potential degradation of the liner.

Ideal candidates for revision ankle replacement include people who experience loosening and subsidence (caving in) of the talar component. The company doesn’t recommend revision surgery to those who haven’t experienced issues with their implants.

Exactech manufactures primary hip replacements, revision surgery hip replacement systems and individual components. Models of these medical devices include Alteon, Spartan and BIOLOX delta. Research shows that Exactech’s hip replacements have a low risk of replacement at five years.

Hip Arthroplasty published a study in 2022 reporting that the Novation replacement had a 92.4% survival rate at five years. Not all Exactech hip replacement components have performed as well. For example, the Exactech Connexion GXL polyethylene liners may cause a higher rate of osteolysis (bone tissue damage) around the hip socket and thigh bone.

Serious complications are rare, but they may require revision hip replacement surgery.

In June 2021, Exactech recalled the Connexion GXL acetabular polyethylene liner. The company said the recall was necessary because of premature prosthesis wear, which contributed to the early failure of hip replacements and the need for revision surgery.

In January 2024, the FDA issued a Drug Safety Communication warning to the public about Exactech’s Equinoxe Shoulder System, which was also packaged in nonconforming bags from 2004 to August 2021. In April 2024, Exactech voluntarily recalled its shoulder replacement devices shipped in defective packaging.

In 2012, Irwin Weiss had surgery to replace his knee and received a replacement knee device called an Optetrak Polyethylene Tibial Insert. Later, researchers discovered that this device was not packaged correctly, which caused its materials to wear out much sooner than they should have.

This early breakdown led to inflammation in Weiss’s body, resulting in bone damage, severe pain and harm to surrounding tissue, according to the complaint in Weiss’s Exactech lawsuit complaint. By 2022, Weiss had to undergo another major surgery to fix these issues and replace the artificial joint.

Increased Risk of Revision Surgeries
Because of the improper packaging, many patients like Weiss required additional surgeries much earlier than expected, according to court documents. His lawyers claim this problem was primarily due to a lack of protection from the packaging, causing parts of the device to loosen, leading to permanent bone loss and difficulty moving.

Long-Term Impact on Quality of Life
According to his complaint, Weiss continues to face serious health issues, including ongoing pain, trouble walking and a change in his ability to get around. Additionally, his lawyers say that the financial and emotional strain from ongoing medical treatment, rehabilitation and lost income has taken a significant toll on his life.

This situation highlights how essential it is for device manufacturers to have strict quality controls in place when making medical devices. These controls help ensure that patients are not at risk because of careless manufacturing practices.

If your Exactech replacement ankle, knee, shoulder or hip device was recalled, schedule an appointment with your surgeon to discuss your concerns and options. They will take X-rays and perform other diagnostic tests to assess premature wear or bone and tissue damage.

Surgeons should also monitor patients without implant problems. Exactech does not recommend revision surgery for asymptomatic people. If you develop problems, discuss the risks and benefits of revision surgery with your surgeon.

If Exactech recalls your replacement device, you may go through the Kroll Restructuring Administration for reimbursement. Due to Exactech’s recent bankruptcy, Kroll — a third-party business restructuring company — handles its recall claims.

People who have recalled devices and experienced complications may qualify to file a legal claim. A qualified lawyer may help you get compensation for medical costs, lost wages, pain and suffering.