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Exactech, a medical device manufacturer, has faced a series of recalls and lawsuits over its joint replacement products. Since 2021, the company has recalled hundreds of thousands of hip, knee, ankle, and shoulder implants due to defective packaging and other issues, affecting devices manufactured as far back as 2004. As reported by CBS News, these recalls have led to a surge of lawsuits, with over 1,600 cases now consolidated in federal court, as patients allege premature device failure and the need for revision surgeries.
Exactech device recalls
The first recall was issued in June 2021 for Connexion GXL hip implant liners due to premature wear risks. This was followed by a series of expanded recalls: in August 2021 for knee and ankle implants, in February 2022 for additional knee and ankle devices, and in August 2022 for all hip implant polyethylene components. In June 2023, Exactech recalled its shoulder replacement systems due to issues with the devices and surgical tools. The FDA also issued a safety communication in January 2024 regarding the Equinoxe shoulder system, though Exactech did not voluntarily recall this product. These recalls primarily stemmed from defective packaging that allowed oxidation of the polyethylene components, potentially leading to early device failure and the need for revision surgeries.
Scope of affected devices
The recalls affected approximately 657,391 Exactech devices manufactured between 2004 and August 2021. By April 2022, an estimated 147,732 knee and ankle devices had been implanted in patients in the United States since 2004. The scope of affected products includes:
- Optetrak, Logic, and Truliant knee replacement systems
- Vantage total ankle replacement system
- Novation, Acumatch, and MCS hip replacement devices with GXL liners
- Equinoxe shoulder replacement system
These recalls have been classified as Class II by the FDA, indicating potential for temporary or medically reversible adverse health consequences. Individuals affected should seek advice from legal professionals with expertise in defective medical product claims.
Ongoing lawsuits overview
As of September 2024, 1,670 lawsuits are pending in multidistrict litigation in the U.S. District Court for the Eastern District of New York. These cases allege injuries such as device failure, bone loss, pain, and the need for revision surgeries due to Exactech’s defective products. The first bellwether trial is scheduled for July 2025, with no settlements or verdicts reached yet. Some attorneys estimate potential settlements could range from $100,000 to $300,000 per case, though this remains speculative. Additional lawsuits are also proceeding in state courts, particularly in Florida.
Whistleblower settlement 2010
Prior to the current wave of recalls and lawsuits, Exactech faced legal trouble in 2010 when it settled a whistleblower lawsuit with the U.S. Department of Justice for $3 million. The lawsuit alleged that the company had provided kickbacks to orthopaedic surgeons to encourage the use of their hip and knee implants, and had submitted false claims to Medicare. This earlier settlement highlights a pattern of legal challenges for the company, predating the more recent issues with device recalls and patient lawsuits.
Who can file an Exactech lawsuit?
Individuals who have received Exactech hip, knee, or ankle replacements and experienced complications such as pain, swelling, implant loosening, or the need for revision surgery may be eligible to file an Exactech lawsuit. These lawsuits seek compensation for medical expenses, pain and suffering, and other damages resulting from the use of defective Exactech products. Typically, patients whose implants involved recalled polyethylene components are the primary candidates for legal action against the company. Consultation with an experienced medical negligence lawyer is essential to evaluate eligibility and ensure proper legal representation.
