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Which Exactech Inc. artificial joints are being recalled?

A wide range of the company’s defective joints are under recall, including defective hip joints, defective knee joints and defective ankle joints. Hundreds of thousands of joints manufactured and implanted between 2004 and 2022 are being recalled. Visit our Exactech joint recall pages for more information. 

Why are they being recalled?

Improper packages of a critical plastic component is resulting in premature wear and damage that can result in friction, loss of mobility, loss of bone, pain and other issues. Revision surgery may be required. 

How do I know if my joint is being recalled?

The company, and or your surgeon or physician, should notify you by letter.

Why are so many of the company’s artificial joints under recall?

Improper packaging of a key plastic component can result in oxygen and other environmental contaminants reaching the joint before implantation. This can result in oxidation that causes premature degradation and damage to the component. Unfortunately, the company used the same type of packages across all of its joint products for nearly 20 years before issuing the recall. 

What does the plastic component do?

The plastic component is designed to provide comfort and proper fitment, as well as to facilitate movement. Exactech reports degrading of the component can result in “reduction of mechanical properties” of the joint. For patients, this may mean pain and loss of movement.  

What are the consequences to the patient if their joint proves defective?

Complications can include mobility issues, pain, bone loss, instability and other problems. Revision surgery may be required. 

What is the company doing about it?

The company has hired a third-party administrator to process claims for “out-of-pocket” expenses if it determines you are eligible after a medical examination. Essentially, Exactech might pay for some of the expenses associated with attempting to repair its defective product, or it might use the examination to deny and defend your claim. 

What should I do about it?

We recommend anyone who receives notice to contact an experienced Colorado defective medical product attorney for a free and confidential consultation to discuss your rights, including the best course of action to correct your defective joint, and a determination of all of the compensation to which you may be entitled. 

Why should I choose the McLaughlin Law Firm?

Our defective medical product lawyers in Colorado have significant experience in representing clients dealing with defective artificial joints. The McLaughlin Law Firm has what it takes to manage the key details, evidence, and proceedings to set these cases up for success. 

Our representation includes: 

Our defective product attorneys in Denver have extensive experience litigating claims involving artificial joints and other defective products and have won numerous multi-million dollar awards on behalf of our clients. If you are suffering from surgical complications or issues related to a defective hip implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.

Implantation of a defective medical device can cause a wide range of issues, and necessitate the significant pain and inconvenience associated with revision surgery and recovery. 

In the case of Exactech Inc. the company has recalled hundreds of thousands of partial and complete hip, knee and ankle joints manufactured and implanted in the United States over the last 20 years. The defect is a result of faulty packages of plastic parts, which can prematurely wear or degrade in the body. The parts were meant to replace cartilage, absorb some of the pressure and friction within the joint, and facilitate movement. 

3d rendering of total hip replacement

In issuing the recall, Exactech Inc. stated a “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”

The company reports defective packaging may allow oxygen and other environmental contamination to degrade the plastic. If you have received notice from the company of your physician, contact us for a confidential consultation with our defective medical device attorneys in Colorado to determine the best course of action to protect your rights. 

Common consequences of dealing with these defective Exactech implants include: 

As part of the recall of its defective hips, knees, and ankles, Exactech Inc. has hired a third party administrator to determine eligibility for those who might qualify for reimbursement of “out-of-pocket” expenses associated with the company’s attempts to fix its defective products. As part of the process, the company will require you to undergo a medical examination, which may also be used to defend itself against any future claims. If you are suffering from surgical complications or issues related to a defective hip implant, please call the defective medical product attorneys at the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.

Exactech Inc. has expanded its extensive recall of its artificial hip and knee joints to include its artificial ankle joints manufactured and implanted in the United States since 2016.

The ankle joint under recall is the VANTAGE® Fixed-Bearing Liner Component.

For more than 20 years, Exactech Inc. used defective packaging across a wide–range of its artificial joint products and has already recalled hundreds of thousands of artificial knee and hip joints manufactured and implanted since 2004. 

A critical component, a plastic inserts meant to facilitate fitment and movement as well as increase comfort and protect bone and surrounding tissue from the consequences of metal components rubbing together, was packaged in vacuum bags that did not contain an additional oxygen barrier layer of Ethylene Vinyl Alcohol (EVOH). This can allow increased oxidation of the plastic, leading to a reduction of mechanical properties of the knee joint, premature wear and joint, bone and tissue damage. 

x-ray of an injured ankle

“After extensive testing, we have confirmed that most of our total knee replacements (TKR), partial knee replacements, (PKR), and total ankle replacements (TARs) with polyethylene (plastic) components and inserts manufactured since 2004  were  packaged  in  out-of-specification (referred  to hereafter as “non-conforming”) vacuum bags,” the company said in a letter to surgeons and patients. 

Consequences of Defective Exactech Ankle Joints

The company acknowledged the following risks:

Patient Rights after Implantation of Defective Joints

The company has hired a third-party administrator to review claims for potential payment of out-of-pocket expenses associated with revision surgery and other medical procedures that will attempt to fix its defective joint. Exactech will require patients to undergo a medical examination, which it will use to determine eligibility or denial, and which it may use to later defend itself against a claim. 

Our defective medical device attorneys in Colorado urge anyone dealing with issues related to joint replacement surgery to contact an experienced law firm. The reality is that many of these joints have proven defective over the years. This new generation of polymer lined joints was designed after first-generation metal-on-metal joints resulted in a host of issues, ranging from bone loss, to infections caused by metal shavings in surrounding tissue. 

Patients undergo joint replacement in an effort to improve mobility and quality of life. These surgeries are expensive, painful, and often necessitate a lengthy recovery process. Complications that result in the need for revision surgeries may result in a more difficult recovery and more uncertain outcomes, particularly for older patients. A failed joint may also have damaged other components or surrounding bone and tissue.

Additionally, allowing Exactech to minimize its costs by paying patients the bare minimum while attempting to repair a faulty joint may not be in the patient’s best interest. An experienced defective medical device attorney in Colorado will be in the best position to determine all of the compensation to which you are entitled and can help you determine the best medical solution for your situation. If you are suffering from surgical complications or issues related to a defective ankle implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.

Exactech Inc. has announced a recall of its artificial knee product because of the possibility of a degrading plastic component, an issue similar to the one that forced a recall of its artificial hips in 2021. 

The company reports defective packaging may allow oxygen and other environmental contamination to degrade a key plastic component prior to implantation. Resulting oxidation can cause the plastic to prematurely wear or become damaged after implantation into the patient’s body. 

The recall involves both partial and total knee replacement products, impacting more than 133,000 artificial knees manufactured and/or implanted in the United States between 2004 and 2022.

Recalled products include: 

knee replacement x-ray

OPTETRAK® Unicondylar Tibial Components     

OPTETRAK® All-polyethylene CR Tibial Components     

OPTETRAK® All-polyethylene PS Tibial Components

OPTETRAK® B-Series Ps Tibial Insert

OPTETRAK® CC Tibial Inserts

OPTETRAK® CR Tibial Inserts

OPTETRAK® CR Slope Tibial Inserts

OPTETRAK® PS Tibial Inserts

CUSTOM OPTETRAK® Angled PS Insert

CUSTOM OPTETRAK® CC Tibial Insert

OPTETRAK® HI-FLEX® PS Tibial Inserts

OPTETRAK “MOMB” Non-Mod Molded Insert

OPTETRAK® RBK PS Tibial Components

OPTETRAK Logic®

OPTETRAK Logic® CR Tibial Inserts     

OPTETRAK Logic® CR Slope Tibial Inserts

OPTETRAK Logic® CRC Tibial Inserts

OPTETRAK Logic® PS Tibial Inserts

OPTETRAK Logic® PSC Tibial Inserts

OPTETRAK Logic® CC Tibial Inserts

TRULIANT® CR Tibial Inserts     

TRULIANT® CR Slope Tibial Inserts

TRULIANT® CRC Tibial Inserts

TRULIANT® PS Tibial Inserts

TRULIANT® PSC Tibial Inserts

Defective Knee Implant Claims in Colorado 

A plastic insert that fits between the femoral component and tibial component and acts as the cushion or cartilage for your replaced knee joint, known as the tibial polyethylene, is a critical component of your new knee.

A standard knee replacement has four parts:

The plastic inserts were packaged in vacuum bags that did not contain an additional oxygen barrier layer of Ethylene Vinyl Alcohol (EVOH). That can allow increased oxidation of the plastic, leading to a reduction of mechanical properties of the knee joint. 

Premature wear or damage to the plastic component can result in pain, osteolysis bone loss, loss of mobility and the need for revision surgery or other medical procedures. While the company has established a claims process and hired a third-party administration, the process clearly leaves it in charge of determining the needs of the patient and the amount of reimbursement. 

“In those cases where the plastic has worn out earlier than expected or has been damaged, we will evaluate your knee replacement and decide whether additional treatment is needed,” Exactech stated. “After this evaluation is complete, we will decide if additional treatment, including revision surgery, is necessary.”

Those dealing with defective knees or other faulty medical devices should not rely upon the company to make things right. At best, you will be reimbursed for a portion of medical expenses, without regard to pain and suffering, lost wages, reduced quality of life, or the long-term effects of patching up a defective artificial knee. Contacting an experienced defective knee implant attorney in Colorado will best help you determine your options, while protecting your rights to recover all of the compensation to which you are entitled. If you are suffering from surgical complications or issues related to a defective knee implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.

A recall has been issued for the Exactech Connexion GXL acetabular liner in hip replacements by the device manufacturer, Exactech Inc. Early failure of the liner as a result of wear and tear means patients who had the liner implanted during primary or revision surgery may require additional medical procedures to repair damages caused by this defective medical device. 

In issuing the recall, Exactech Inc. stated a “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”

The company reports defective packaging may allow oxygen and other environmental contamination to degrade a key plastic component prior to implantation. Resulting oxidation can cause the plastic to prematurely wear or become damaged after implantation into the patient’s body. 

A study by the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine found that the Exactech hip liner suffers early failure in some patients. Doctors studied patients who required revision surgery after having a complete hip replacement using Exactech Connexion GXL acetabular liners between 2009 and 2019. 

3d rendering of total hip replacement

A review of the database maintained by the Food and Drug Administration revealed more than 25 percent of reporting patients who required revision surgery needed the procedure because of “plastic wear” or “osteolysis” bone loss caused by plastic wear that resulted in friction between metal components. The length of time between the initial hip replacement and the revision surgery was just 6.5 years.

“The Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis. We recommend close surveillance of patients with this bearing surface,” the authors wrote.

The hip liner is inserted into the leg of a patient during complete hip replacement. The job of the liner is to allow the metal or ceramic components of the artificial hip to move freely.

Exactech issued an “Urgent Medical Device Correction” notice in July 2021, impacting the more than 89,000 devices distributed in the United States. 

Claims for Defective Hip Implants in Colorado

As part of the recall, Exactech has set up a claims procedure to reimburse for out-of-pocket expenses and has hired a third-party administrator to handle the process. But the reality is the company process will likely do little to compensate patients suffering from pain, discomfort, loss of mobility, and the need for revision surgery or other medical procedures. Of additional concern is the fact that the company’s solution is to replace part of the implant, which could further complicate long-term reliability.

An experienced defective medical device attorney in Colorado will be in the best position to advise clients of their options while moving to recover compensation for all of the damages to which they are entitled. 

The McLaughlin Law Firm has what it takes to manage the key details, evidence, and proceedings to set these cases up for success. The steps we take to strengthen medical device injury cases and position them for favorable outcomes include conducting a thorough examination, preservation of evidence, use of qualified legal and medical experts, and comprehensive pretrial negotiations that are backed by extensive case preparation and a long track record of success in the courtroom.

If you are suffering from surgical complications or issues related to a defective hip implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.

All consultations are free. Contacting our firm to discuss your potential case does not result in any expense to you.

1890 North Gaylord Street
Denver, CO 80206
(720) 463-1516