Exactech Implant Recall Lawyer
When arthritis, an injury, or other medical condition causes the body’s joints to deteriorate, surgical replacement may be the only viable pain relief option for some patients. Joint replacement surgery can decrease the pain associated with damaged joints and restore function and mobility.
Exactech is a company that develops and produces medical-grade orthopedic implants and instruments used for joint replacement surgeries. The company develops and manufactures numerous devices, including artificial shoulder joints, knees, hips, foot, and ankle joints. Unfortunately, risks associated with many Exactech products triggered a nationwide recall of joint replacement devices and inserts, liners, and cups.
At Swenson & Shelley, we understand how defective medical devices can impact a patient’s health and quality of life. Our mass tort attorneys know how to fight for you. We have the resources to tackle even the most complex cases and can help you hold careless corporate entities accountable for their careless actions.
Are you experiencing medical complications associated with an Exactech implant or medical device? If so, contact our office today and speak with a compassionate Exactech recall lawyer about your situation. We want to help you pursue the money you deserve.
What Are the Issues with Exactech Implants?
In June 2021, the company initiated a recall of its hip implant acetabular liners for its Novation hip replacement system, citing premature wear along the device’s edges. Eventually, the recall expanded to include hundreds of thousands of defective Connexion GXL and conventional ultra-high molecular polyethylene hip liners. These products have been manufactured since 2004.
In August 2021, the company recalled knee and ankle implant devices, including tibial inserts and components from multiple product lines.
What are the issues with Exactech implants? Many items recalled, like inserts, liners, and cups, contain polyethylene. Polyethylene is a plastic polymer that can degrade when exposed to oxygen. Protecting the integrity of the product means the devices must be packaged in oxygen-resistant vacuum bags. These bags must also contain a second barrier layer of ethylene vinyl alcohol for additional protection.
The U.S. Food and Drug Administration (FDA) reports Exactech implants may have been placed into defective packaging and bags, exposing the product to the degrading effects of oxygen and compromising the products regardless of the device’s label or shelf life. The defective bags can lead to oxidation of the polyethylene polymer, causing issues with the following:
- Early device wear
- Excessive device wear
- Device failure
- New or worsening pain
- Bone loss
- Need for revision surgery
In an Urgent Medical Device Correction, Exactech admitted that 80 percent of the inserts it manufactured since 2004 were placed in non-conforming packaging, potentially eroding the product’s integrity.
How a Mass Tort Attorney Can Help
At Swenson & Shelley, our Exactech recall lawyers want to help you recover the compensation you deserve if a defective Exactech implant or other medical device injures you. Our firm has helped thousands of people get their lives back on track by recovering meaningful compensation through the legal system. Big companies must be held accountable for their careless actions. Our team has the experience and resources to go head-to-head with prominent companies to seek justice for you.
Here’s what you can expect when you work with Swenson & Shelley:
- We carefully listen to you and discuss your situation in detail.
- We review all documents and medical information.
- Our team outlines your legal options for recovering compensation.
- We prepare an honest assessment of what comes next.
- We aggressively advocate for the compensation you deserve.
- We prepare a case for court if necessary and represent you at trial.
You deserve to focus on your recovery, not the legal ins and outs of holding a careless company accountable. Let us work with you and offer you peace of mind as we pursue the money you need.
Here’s more information about Exactech, the implants, and legal action:
How do I know if I received a defective implant?
You can locate product information about recalled devices online. You can also share your concerns with your doctor or physician and get their help determining whether your specific implant is the subject of a company recall.
Is there a class action lawsuit against Exactech I can join?
There is not currently an Exactech class action lawsuit. Instead, the case is moving forward as multidistrict litigation, which transfers all similar cases to a single court to handle. The Exactech cases have been transferred to the Eastern District of New York. In multidistrict litigation, the court hears a few test cases so the parties can determine how the remaining cases will unfold so they can potentially reach a settlement.
How long could an Exactech class action or mass tort lawsuit take?
The litigation process against a large and powerful corporate entity can be lengthy. It takes time to gather evidence and build a compelling case that offers injured victims the best opportunity of recovering the compensation they need. Collecting the necessary information and documents to hold a company accountable for its careless actions can take months or even years. Rushing the process can limit the amount of money you can recover. There may also be other cases that have been filed before yours that must be resolved before the court will hear your case, which can further extend the potential timeline of the case.
How much is my Exactech implant lawsuit case worth?
Several factors can play into the value of your Exactech implant lawsuit. An experienced Exactech recall lawyer can evaluate your situation and more accurately estimate the value of your lawsuit.
Types of Implants
Exactech didn’t initiate a recall of their orthopedic products until 2021 and 2022. However, products impacted by defective packaging may have been manufactured since 2004. Additionally, the company only notified Exactech agents, representatives, and distributors of the initial recall. Healthcare providers and patients remained in the dark until a subsequent recall.
The confusion and lack of communication on the company’s part made it challenging for patients to know whether their implant or device was part of the multiple rounds of recalls.
Exactech products impacted by the recent recalls include the following knee and ankle replacement devices:
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak All-Polyethylene PS Tibial Components
- Optetrak Hi-Flex PS Tibial Inserts
- Optetrak Logic CR Tibial Inserts
- Optetrak CR Tibial Inserts
- Optetrak CR Slope Tibial Inserts
- Optetrak Logic PS Tibial Inserts
- Optetrak Logic PSC Tibial Inserts
- Optetrak Logic CC Tibial Inserts
- Optetrak PS Tibial Inserts
- Optetrak Logic CR Slope Tibial Inserts
- Optetrak Logic CRC Tibial Inserts
- Truliant PSC Tibial Inserts
- Truliant CR Tibial Inserts
- Truliant PS Tibial Inserts
- Truliant CR Slope Tibial Inserts
- Truliant CRC Tibial Inserts
- Vantage Fixed-Bearing Liner Compon
GXL hip liners may also threaten patient safety and be at risk for higher wear rates. These products include:
- MCS Liners
- Novation Liners
- Acumatch Liners
You can find a complete list of recalled products on Exactech’s website, including specific product lines and brand names. If you are concerned about your implant, you can also talk to your doctor about the dangers of your specific implant or medical device.
Illness, Injuries, Symptoms, and Side Effects
Defective packaging may have exposed implants to the harmful effects of oxidation. Oxidation degrades the quality of the implant and can lead to devastating illnesses and injuries when microscopic flecks of these medical devices break off and enter surrounding tissues and bones of the body, including soft tissues like cartilage.
Common symptoms that indicate you may be experiencing complications associated with a defective Exactech implant include:
- New or worsening pain
- Swelling in the area of the implant
- Instability of the joint
- Inability to bear weight on the joint
- Loss of range of motion
- Clicking or grinding sounds
Additional complications that can manifest over time may include:
- Chronic pain
- Impaired mobility
- Osteolysis or bone loss
- Necrosis of bone or soft tissues surrounding the implant
- The buildup of fluid around the joint or implant
These complications can result in the need for additional revision surgeries. They may also lead to physical disability, disfigurement, amputation, or death.
The FDA regularly posts updates about the Exactech recall and other medical device recalls impacting patients across the U.S. As recently as March 2023, the agency reminded patients and healthcare providers to check joint replacement devices manufactured by Exactech between 2004 and August 2021. The organizations also advise patients about starting a dialogue with their healthcare providers.
As of May 2023, there are nearly 400 pending lawsuits against Exactech. Since litigation is in its early stages, there have been no reported settlements or verdicts. Some of these cases allege that Exactech knew about the non-conforming packaging since 2004 but did nothing to correct it.
At Swenson & Shelley, our results speak for themselves. Our experienced mass tort attorneys have earned clients millions in settlements and verdicts.