Exactech Joint Replacement Device Safety and Recall Information
Multiple Exatech recalls occurred after packaging issues damaged plastic parts on knee, hip and ankle replacement joints. Patients whose joints were part of the Exactech knee replacement recall, or the hip or ankle recalls, may be able to pursue an Exactech lawsuit if their joint failed prematurely.
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- Last update: August 14, 2025
- Est. Read Time: 4 min read
- Exactech joint replacements manufactured between 2004 and August 2021 were recalled
- Problems with packaging caused oxidation of the plastic parts, leading to premature failure
- Exatech was offering a compensation fund for affected patients but the fund is no longer accepting new claimants
Many Exactech knee, ankle and hip joint replacement products were negatively impacted by defective packaging. These packaging problems led to oxidation, causing the devices to quickly wear down, crack or fail. While Exatech has recalled these dangerous medical devices, the company’s actions come too late for many people who had the replacement joints implanted and who are now facing complications.
The company established a program to compensate victims, but that program closed after the company, just weeks before Exatech lawsuits were scheduled for trial, filed for bankruptcy. This makes it incredibly difficult for patients to hold the company liable for the damage done.
This guide will detail what Exactech joint replacements were used for, why they were recalled and what to do if you believe you have a recalled implant. It will also discuss the FDA’s actions related to this topic and what financial recourse you may take since Exactech is no longer accepting reimbursement applications.
What Are Exactech Joint Replacements?
Exactech manufactures knee, hip, ankle and shoulder joint replacement devices that are intended to address osteoarthritis, osteonecrosis, rheumatoid arthritis and other functioning or structural issues related to those joints. The devices have also been used to improve existing joint replacements that failed, as long as enough bone and soft tissue are still present in the affected area.
Unfortunately, significant problems with Exactech’s joint replacement products have been identified, with many resulting in Exactech recalls. In some cases, patients require revision surgery.
Overview of the Recalled Exactech Devices
Between 2004 and August 2021, Exactech joint replacement devices were placed in defective packaging, which has resulted in a wide variety of products being recalled.
- Knee replacement joints, including Optetrak, Logic and Truliant devices
- Hip replacement joints, including GXL hip liners for Novation, Acumatch and MCS devices, as well as Connexion GXL & Conventional Hip Liners
- Ankle replacement joints, including Vantage devices
- Optetrak® Advanced Patella components and Tibial components
- The Equinoxe Shoulder System
Hundreds of different specific models of these devices were impacted. Exactech has a complete list on its website, which includes the item number, product description, brand name and device identification number.
Why Were Exactech Devices Recalled?
Many Exatech devices manufactured between 2004 and August 2021 were recalled in 2021 and 2022 due to packaging problems. The bags holding the devices were missing a barrier layer that was essential to protecting the devices from oxidation, a chemical reaction that occurs upon exposure to oxygen.
Oxidation can make plastic degrade over time, and joint replacements contain plastic. This resulted in many of the devices wearing out, fracturing, cracking and otherwise failing prematurely.
Signs of a Failing Exactech Implant
While Exatech joint replacement devices are more likely to fail prematurely due to the oxygen exposure, this does not mean every device will fail. As a result, patients need to know the symptoms of a failing device.
These symptoms include:
- Worsening or new pain or swelling
- The joint becoming unable to bear weight
- Grinding noises or other noises
- Weakness around the area where your device was implanted
- Swelling, redness or stiffness of the affected joint
- Instability
Symptoms can develop slowly over time, and some patients experience a delayed diagnosis after their implant begins to fail.
The FDA recommends that doctors monitor patients who have had an affected device implant. This can include taking X-rays if patients are showing symptoms to determine if the replaced joint is intact.
What Should You Do if You Have a Recalled Exactech Implant?
If you have an Exactech implant, you should check the website’s database of affected devices to see if yours made the list of recalled items, monitor yourself for symptoms and see your doctor as scheduled and if you have concerns. You can get a copy of your surgical records from your doctor to find out the model number and other details about your replacement joint.
Keep a record of any symptoms, even if they’re mild or infrequent, and discuss them with your doctor. Minor issues can progress over time, so early detection is important.
Is Revision Surgery Always Required?
Not all devices fail, so the FDA doesn’t recommend that you remove a well-functioning replacement joint. If you’re worried, your doctor might order X-rays or other tests. Otherwise, they may recommend watchful waiting to see if problems develop.
However, revision surgery is recommended if you have joint pain or weakness that is getting worse over time, if a clinical exam reveals it is caused by the defective medical device.
What Has the FDA Said About Exactech Devices?
The FDA has been actively involved in announcing Exactech recalls, which have occurred over multiple years. For example:
- June 2021:
- Some GXL Liners for Novation, Acumatch and MCS hip replacement devices were recalled because they were failing prematurely. At the time, the reason for the failure was unknown. These hip replacement recalls were a Class II recall.
- October 2021:
- Exactech recalled its Optetrak, Logic and Truliant knee replacement and Vantage total ankle replacement devices. These were also classified as Class II recalls. The company would later expand these recalls in February and issue an Urgent Medical Device Correction in April of 2022.
- September 2022:
- After a broad Exactech recall for all hip devices with polyethylene components packaged in defective bags in August, the FDA deemed this a Class II recall.
- March 2023:
- The FDA issued a safety communication reminding patients and providers about the potential risk of Exatech joint replacement devices manufactured between 2004 and 2021.
- June 2023:
- Exactech recalled its Shoulder GPA Impactor handle due to device defects, not packaging issues. This was a Class II recall.
- January 2024:
- The FDA issued a warning letter alerting patients to problems with Exactech Equinoxe Shoulder System devices. The company initiated a recall in April 2024.
The FDA recall information helps provide clear evidence and instructions about what to do if you have an Exactech device.
Has Exactech Offered To Cover Patient Costs?
Exactech initially offered to provide reimbursement for “certain” out-of-pocket expenses related to joint recalls but ended this program upon restructuring through bankruptcy.
The expenses covered could have included:
- Copays and deductibles
- Reasonable travel costs associated with returning to the surgeon who initially performed the joint replacement surgery
- Some unreimbursed expenses from revision surgery
Since Exactech ended its assistance programs, patients with failed devices are left with very few options. If you have been harmed by a defective replacement joint implanted before the Exactech recall, pursuing a hip replacement lawsuit, knee replacement claim or ankle replacement lawsuit could maximize your chances of being paid for your damages.
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