Medical implant company Exactech filed for bankruptcy in Delaware on Tuesday in an attempt to sell its assets and settle over 2,600 claims involving recalled knee, hip, and shoulder implants.
Owned by the private equity firm TPG, Exactech filed for bankruptcy with $352 million in debt and a sale deal that would give its lenders ownership of the company’s assets. According to court documents, 95% of the company’s lenders favor the selling deal, which is open to more extensive offers.
According to the company, its financial performance started to be negatively impacted by hefty interest payments and Exactech lawsuit costs in the middle of 2023, endangering an otherwise successful business. Over the last 12 months, Exactech has spent $20 million on litigation and recalls.
The company, located in Gainesville, Florida, produces surgical imaging technologies and implants for the knee, ankle, hip, and shoulder. Exactech employs 900 people worldwide and has four production plants in Gainesville, Sarasota, Florida, and Gieres, France.
What is the Knee System Recall for Exactech OPTETRAK?
In February 2022, Exactech, the company that makes the OPTETRAK Comprehensive Knee System, released a URGENT medical device repair. This recall was categorized as a “Class II Recall” by the FDA in the United States.
This indicates that the FDA has concluded that exposure to the product may cause short-term or medically reversible health effects.
What is the Problem with Exactech’s Optetrak Comprehensive Knee Systems?
The manufacturer discovered that one of the layers used in the packaging of the polyethylene insert used in the Total Ankle Replacement and Total Knee Replacement systems did not meet specifications.
The business also found that this layer permits airborne oxygen to permeate the plastic before it is surgically implanted into the knee or ankle. This may cause rust, which could damage the implant, cause early component failure, and harm the patient.
Without this plastic insert, there would be insufficient cushioning to absorb movement stress, which could lead to pain and injury. As a result of this flaw, Numerous Exatech lawsuits were launched nationwide.
Exactech Optetrak Recall: Which Products Are Affected?
Regardless of product labeling or shelf life, the recall covers all polyethylene implants for knee and ankle replacements that were packaged in vacuum bags that were found to be noncompliant with requirements.
Devices and parts that are defective include, but are not restricted to:
In the United States, over 60,000 devices and parts have been implanted in impacted individuals since 2004.
Mass Tort and Class Action Lawsuits for the Company
More than 740 Exatech lawsuits were merged in a Florida state court, while more than 1,840 lawsuits were consolidated in a federal court located in Brooklyn, New York. Jury selection for the four cases chosen for bellwether trials in federal litigation is set to start in 2025.
Exactech has denied the claims, claiming that no agreement has been reached in its attempts to resolve the cases.
A 2018 whistleblower case in a federal court in Alabama also accuses the corporation of defrauding the federal government by requesting compensation for defective and mislabeled knee devices and knee implants that were not medically required or reasonable. The business denies the accusations and claims to have made an effort to settle with the whistleblowers and the US Department of Justice.
According to court records, Exactech’s lenders have agreed to contribute $85 million in new funding to help the business get through its bankruptcy restructuring.
Compensation for Knee Implant Recalls
Exactech and other medical device manufacturers are legally obligated to guarantee that their goods are safe and do not harm users when used as intended. As a result of this obligation, manufacturers are held rigorously accountable for any hidden design faults or harmful defects. What we have here is this.
In all honesty, the Exactech recall admits that the knee replacement implants had a manufacturing flaw (faulty packaging). Therefore, Exactech could be responsible for any harm or losses caused by this flaw.
If the implant failed and caused discomfort or the need for revision surgery, anyone who received an Exactech knee replacement system after 2004 may be able to file a product liability case. Plaintiffs who were successful could receive compensation for (a) pain and suffering, (b) treatment and revision surgery costs, and (c) lost wages or income as a result of the implant failure.
Do You Qualify for an Exactech Knee Recall Lawsuit?
It may be possible to pursue damages and compensation for injuries if you have undergone knee or ankle replacement surgery since the year 2004 and have had any of the goods listed in this article surgically implanted.
If so, contact the attorneys at People For Law. We are experts in mass tort cases and have years of experience to help you and the success rate to back us up. Contact us today to schedule your appointment.