Exactech, a global medical device manufacturer, has recalled hundreds of thousands of ankle, hip, shoulder and knee implant devices because of defective parts and packaging that may cause device failure. The company launched a massive recall of all ankle, hip, and knee replacement implant systems manufactured after 2004.
The sweeping recall followed a discovery that the devices might have been packaged in faulty bags, causing oxidation of polyethylene parts fundamental to the implants’ functions.
Recalled replacement implants have been associated with chronic pain and require patients to undergo corrective surgeries to replace them. This has caused patients nationwide to file Exactech lawsuits seeking monetary compensation for their medical bills, pain and suffering, and lost income.
Overview of the Exactech Recall: Affected Devices and Patients
As of 2023, Exactech has 170 recalls on file with the U.S. Food and Drug Administration (FDA).
Exatech recently recalled its Vantage ankle system, an ankle implantable product. The recall is linked to the risk of material degradation within the device. This degradation can cause the device to fail over time, putting patients at risk of infections and physical injuries.
The FDA classifies the Exactech Vantage total ankle system recall as a Class 2 Device Recall. That means that using the faulty implant “might cause medically reversible adverse health complications.” Although the risk of an irreversible adverse health complication is deemed “rare” with a Class 2 Device Recall, many patients have developed long-term complications—emotional, physical, and financial—after using faulty Exactech ankle replacement implants.
Exactech has also recalled all its hip implant systems with its Connexion GXL liner. The Connexion GXL Hip Liners are polyethylene parts that are fitted within hip implantable systems used for primary and corrective hip replacement surgery. These hip implant devices are prone to failure, degrading at a rate that necessitates premature revision surgery in many patients. A 2022 clinical study found that, after receiving a hip implantable device, nearly 47% of patients experienced a significant medical improvement, while approximately 16% developed aggravated outcomes, indicating possible design-related problems adversely affecting the patient’s ability to function and recovery.
Because of the potential risk of deterioration, Exactech recommends that doctors closely monitor their patients for symptoms that require corrective surgery. Common symptoms of Exactech hip implant failure complications include stiffness, debilitating pain, weakness, joint pain, and difficulty walking. The Exactech hip implant recall focused on MCS, Acumatch, and Novation liners.
Like the Vantage total ankle system recall, Exactech’s hip implant systems are a Class 2 Device Recall. Patients who have already undergone revision surgery should consult an attorney about recovering their expenses, and those who haven’t should continue to monitor their condition and talk with a doctor to establish if and when the surgery will be necessary.
In 2022, Exactech recalled its knee replacement implant devices. This recall potentially affects hundreds of thousands who received knee implants from 2004 to 2022.
One of the key issues with Exactech’s knee replacement systems is the implant packaging. The FDA discovered that the packaging didn’t adequately protect the implants from oxygen exposure before implantation. This, ultimately, created a risk for oxidation, which could substantially increase the rate of the implants’ deterioration.
For many, the first symptoms of an Exactech knee implant failure are instability, swelling, a clicking or grinding sensation, and excruciating pain while walking. Suppose you are experiencing these symptoms and received an Exactech Optetrak, Optetrak Logic, or Truliant implant in 2004 or later. In that case, you should consult your doctor about the potential need for revision surgery.
The company has also issued recalls on its implantable shoulder replacement devices. The recalls relate to issues with the replacement devices and the tools the company supplied for use during surgery.
Like other joint replacement implants, Exactech’s shoulder replacement devices can cause several health complications, including instability, infections due to device failure, and periprosthetic bone fractures.
Long-Term Implications of the Exactech Recall
If left untreated, recalled implantable systems can cause various health complications. Those complications could be severe and even life-threatening in some instances. Sometimes, patients may need to undergo revision surgery to protect their safety because certain complications can’t be fixed except by replacing the faulty implant device.
Other long-term complications that one may experience due to Exactech implantable system failure include:
- Infections. When Exactech implants degrade, they can release dangerous chemicals and particulates into the body. This may cause infections, which can cause severe health problems if ignored or unnoticed for long.
- Joint failures. A patient’s joints may fail due to deterioration or other implant issues, causing internal damage to the joints, nerves, tissues, and surrounding bones. This can also lead to falls and other accidents.
- Periprosthetic bone fractures. Although an Exactech implantable device may not fail completely, loosening, weakening, and other issues affecting the implant can cause periprosthetic bone fractures. These fractures are often difficult to treat because the fracture and the problems with the implant itself all need to be addressed. They are often dangerous for older patients.
Another real concern about the Exactech implant recall is patients’ financial and non-financial expenses. Regardless of whether you need revision surgery, dealing with a recalled Exactech implant can be quite costly. You may incur a significant medical debt, and if you can’t work during the recovery process, you might struggle to pay other bills because of the lost wages.
Pain and suffering, limited mobility, and other complications could also adversely affect your daily life. Luckily, patients can recover all the expenses in many lawsuits. Exactech is facing legal actions related to its faulty implantable devices nationwide, and, by issuing several recalls, the company may have acknowledged responsibility in many lawsuits. Many victims who haven’t filed their allegations can still do so, and if you feel you may have a claim, you should discuss your legal options with an attorney. Many product liability attorneys offer free, no-obligation legal consultations.
Timeline of Key Events in the Exactech Litigation
Patients who developed health complications after receiving Exactech’s joint replacement devices are filing lawsuits against the company. In 2022, the Judicial Panel on Multidistrict Litigation (JPML) consolidated Exactech lawsuits into an MDL in the United States District Court of the Eastern District of New York.
An MDL is a special federal legal process that speeds up mass tort lawsuits.
When many people are affected by the same product or company, the federal court system merges the lawsuits into a single district court, allowing for consistency of decision-making and pretrial evidence discovery.
As of April 2025, there are 1,839 lawsuits against Exactech. The Exactech recall lawsuits focus on allegations that faulty ankle, hip, and knee implants have caused adverse consequences, like bone loss, premature failure, and the need for corrective surgeries.
Complainants claim that Exactech didn’t adequately warn the public about those risks.
Complications from Exactech joint replacement devices can cause mobility issues, severe pain, and expensive medical procedures, substantially affecting one’s quality of life.
In November 2024, 1806 Exactech hip, ankle, and knee replacement lawsuits were filed, increasing to 1,839 claims in December, with 33 new Exactech recall lawsuits added.
That increase shows ongoing anxiety among patients with health problems related to Exactech joint replacement devices.
If you or a family member developed injuries from an Exactech joint replacement system, you might qualify to file an Exactech implant recall lawsuit and pursue monetary compensation.
Exactech’s Response and Bankruptcy Filing
In October 2024, Exactech and four affiliated debtors filed for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court in Delaware. The lawsuits are pending before Honorable Judge Laurie Selber Silverstein (Lawsuit No. 24-12441).
The company seeks to sell all its assets and resolve the lawsuits against it over recalled ankle, hip, shoulder, and knee implants.
Due to the bankruptcy proceedings, all lawsuits against the company outside the bankruptcy court, including those in the MDL, have now been stayed.
For claimants and the attorneys involved in the MDL, the stay order means that lawsuits can’t progress until further direction from the bankruptcy court. Judge Laurie S. Silverstein is set to have a hearing soon, which will determine where everything is going.
Due to the automatic stay order triggered by Exactech’s bankruptcy filing, no new lawsuits have been added to the Exactech multidistrict litigation in 2025. The number of pending lawsuits remains at 1,839.
Current Status of Exactech MDL and Pending Cases
As of April 2025, there are 1,839 pending cases in MDL No. 3044 before the U.S. District Court of the Eastern District of New York. Thus far, no court trials or approved settlements exist in the multidistrict litigation. Also, there are over 700 pending lawsuits against Exactech in a merged Florida state court action.
In October 2024, the court modified the bellwether trial that was scheduled:
- The Tarloff trial was expected to take place on September 29, 2025.
- The Larson trial was set to start on November 10, 2025.
However, Exactech’s bankruptcy filing might modify those trial dates further.
Projections for Exactech Lawsuit Settlements
If you have developed complications after receiving an Exactech joint replacement device, you may be concerned about the possibility of recovering monetary compensation after filing a lawsuit.
Although Exactech ankle, hip, and knee replacement lawsuits are still in early stages, you must understand the elements that may determine the average settlement amounts in these lawsuits.
There’s no concrete data on the average Exactech lawsuit settlement amount because the legal process is ongoing.
However, some legal experts estimate that the Exactech lawsuit settlement amounts will range between $50,000 and $300,000.
The actual figure will depend on various components, including:
- Individual plaintiff details: Factors like the seriousness of your condition, the effect on your quality of life, and the extent of damages will play a key role.
- Medical costs: The expenses related to current medical bills, revision surgeries, and rehabilitation are key in determining the settlement amount.
- Lost income and future earnings: If the Exactech implant affected your ability to work, causing lost income or reduced future earning capacity, those financial losses will also play a fundamental role in determining your settlement amount.
- Pain and suffering: The emotional and physical distress caused by the defective implant and subsequent complications are also crucial in determining your compensation amount.
- Legal help: Having an experienced Exactech attorney representing your lawsuit might affect the settlement amount you receive. A skilled lawyer will fight to ensure you get full, fair compensation.
- Liability contemplations: The level of negligence assigned to Exactech for defective joint replacement devices will also be pivotal in determining the compensation you receive.
It’s imperative to note that although our projections give you a picture of possible Exactech lawsuit settlement amounts, it’s not certain that your claim will result in monetary compensation.
Each lawsuit is different, and thus, outcomes will vary depending on an individual’s situation and the proof provided.
Qualifying for an Exactech Lawsuit: Eligibility Criteria
You may be eligible to join the Exactech MDL and seek monetary compensation if:
- You received an Exactech ankle, hip, or knee replacement after 2003.
- You developed complications or needed revision surgery because of the implant failure.
Even though you haven’t developed any complications, you might still qualify to file an Exactech claim if you have a recalled Exactech implant.
To determine if you qualify for compensation and join the Exactech MDL:
- Check your medical documents or contact your doctor to confirm if you got an Exactech implant.
- Document all the symptoms or complications you’ve experienced after your joint replacement surgery.
However, given the complicated nature of such lawsuits, it’s wise to contact an attorney as soon as possible. They can help you determine if you’re eligible to file a claim and safeguard your rights to legal action.
How Can Patients Check If Their Implant Is Part of the Exactech Implant Recall?
Any patient who has had a total knee replacement, partial knee replacement, or ankle replacement in or after 2004 must check to determine whether their implant was affected by the Exactech implant recall. Check if you have documents that list your implant’s manufacturer and serial number. If you don’t have those documents, contact your doctor to find that information. If you received an Exactech implant, the company’s recall check website allows you to enter the serial number and determine if your implant is affected by its recall.
Steps to Take if You Have a Recalled Exactech Implant
Learning about your legal options is one of the key steps you should take if you have a recalled implant. If you’re in this situation, here are other crucial steps you should take as soon as possible:
- Seek medical care as soon as possible. The issues with recalled Exactech implant devices can cause several complications, like bone loss and difficulties walking, and addressing those complications as quickly as possible can help reduce the risk of long-term consequences in some cases.
- Start gathering your medical records. Your patient records, hospital visits, scans, and payment receipts could be relevant to your allegations if you’re entitled to compensation.
- Record all your other out-of-pocket costs.
- Document the daily impact of your recalled Exactech implant system. Record how the defective implant negatively impacts your daily life activities.
- Follow all your doctor’s advice to protect your right to financial compensation.
- Consult an attorney about filing a claim. To ensure you make an informed decision about safeguarding your legal rights, you must consult an experienced Exactech recall lawyer about filing a lawsuit.
The Role of Lawyers in Exactech Recall Lawsuits
Mass tort lawsuits like the Exactech implant lawsuit involve complicated medical details and larger corporate defendants. This is one of the key reasons why many plaintiffs hire lawyers to handle their lawsuits.
Here’s how an Exactech recall lawyer can help build your lawsuit:
- Determine how the recalled implant affected you. A skilled Exactech recall lawyer can help you determine how the injury affected you. Whether you’re dealing with job challenges because of limited mobility, physical pain, and other emotional turmoils, an experienced lawyer can help you establish all that. They can also help you determine how much compensation you should seek based on how your injuries have affected your quality of life.
- Collect relevant evidence to document your losses and prove your injuries. In a product liability lawsuit like this, you must link the faulty implant to your complications and losses. That’ll require gathering substantial evidence. A skilled Exactech attorney can use resources such as:
- Your surgeon’s statements
- Your medical documents
- Proof of the implant received
- Invoices and bills for medical expenses
- Scientific data to prove your injuries
- Handle communications with third parties. An MDL litigation is a complicated legal procedure that may involve many third parties. You must meet specific deadlines and file legal paperwork appropriately. Also, you may need to respond to emails, attend necessary hearings and meetings, and so much more. However, hiring an attorney can relieve you of these legal complexities. They can handle all the communications for you. A skilled Exactech lawyer can:
- Submit all the relevant evidence.
- Handle court procedures and processes.
- Negotiate a settlement
- Inform you of all updates in your lawsuit
- Represent you in court mediation or at trial
- Advise you on your legal options
- Seek fair compensation. Exactech recall attorneys are well-trained and have extensive experience in MDL litigations. They have represented many plaintiffs like you, which means they know how to pursue the full, fair financial compensation you deserve.
Resources for Affected Patients and Families
If you or a loved one received a recalled Exactech implantable device, here’s where you can find support and resources:
- Exactech Recall information website: Visit the Exactech Recall information website to establish if the recall affects your implantable system. You can also input your implantable device’s serial number at the Exactech Recall Check website to check its status.
- Contact Exactech at 888-912-0403 for more information and support.
- Consult an attorney specializing in defective medical device litigation to determine your legal options.
- For additional information, contact Kroll, the patient resource, at 833-918-0986.
- Visit the FDA safety communication website to learn the risks associated with Exactech joint replacement systems with faulty packaging.
Suppose you’re affected by the recall in any way. In that case, knowing your legal options is imperative–as you might be eligible for compensation to cover your economic and non-economic damages. At AllConsumer.com, we partner with attorneys familiar with defective medical device litigation and they can help you file a lawsuit to recover full, fair compensation. Sign up for our newsletter to keep up-to-date.
