Why was the Exactech Recall Lawsuit Filed?
Defective packaging and devices led to three consecutive Exactech recall lawsuits in 2021, 2022, and 2024. The faulty packaging diminished the life expectancy of the packaged devices, and they failed earlier than expected. This forced the victims to undergo additional (revision) surgeries to stop the resulting pain. The defective devices loosened up leading to complete failure following their implantation. The result was stiffness that limited range of motions for the victims and pain arising from osteolysis.
The lawsuit still runs and comes under active lawsuits.
Exactech issued a product safety alert warning in June 2021 following the March 2023 FDA report about failing polyethylene liners. The warning stated that their Connexion GXL hip replacement systems manufactured between 2004 and August 2021 were failing before time. Faulty packaging caused the devices to degrade faster than expected, prompting users to file lawsuits.
Latest Exactech Recall Lawsuit Update
A total of 1,770 lawsuits (steadily increasing) are pending against Exacttech multidistrict litigation. The MDL is currently in the U.S. District Court (for the Eastern District of New York) under Judge Nicholas G. Garaufis. The test and trials for the MDL are set to start in June 2025.
No verdicts or settlements have been reached in ongoing Exactech lawsuits. Lawyers are still accepting new clients. Formerly in 2010, Exactech faced legal issues for providing faulty knee replacements. The company paid orthopedic surgeons to use the hip and knee implants for which they also obtained false certifications. The Department of Justice filed a lawsuit themselves against Exactech and the case was settled for $3 million.
Injuries Claimed for in Exactech Recall Lawsuit
These lawsuits have claimed compensation for revision surgeries resulting from several different injuries brought forth by accelerated debris, bone loss (osteolysis), noises in the joint, an inability to bear and support weight, joint swelling and limited mobility, instability due to loosening of components and pain. Typically, the replacement joints should last for 10 years or more.
The ongoing litigation, which points toward a global settlement by Exactech, keeps the device manufacturer under pressure. But certainly enough, Exactech does not want to let the lawsuits go to trial. This might see a settlement in the favor of the plaintiffs come up as early as in the spring of 2025.
What else did Exactech Recall?
There were knee and ankle replacement implants that were recalled earlier. Being a global medical device company from Gainsville, Florida, which has been in operation since 1985, their specialized approach is towards creating implant systems for joint replacement surgeries.
Hip replacement devices aside, Exactech recalled its knee and ankle replacement implants manufactured after 2004. These implants were supposed to correct knee trauma and deformities arising from arthritis. The recall impacted around 150,000 people who underwent total knee arthroplasty in the U.S.
The reason behind is a defective vacuum-seal packaging that led atmospheric oxygen in, thus oxidizing the polyethylene insert components before they were put to use. Polyethylene being an integral part of total knee arthroplasty prosthetics, any premature wear or degradation turns the replacement surgeries into complete failures. It makes a patient’s replaced knee lose its normal functions, bringing discomfort, pain and, in the worst cases, infection. Overall, it’s a total loss of function that’s experienced due to the degraded polyethylene inserts, which bring excessive friction and wear. Only a revision surgery to replace the defective implant can cure the problem.
Patients who have received Exactech implants were recently informed about the recall through a letter sent to their doctors. The letter directs surgeons to cease using Exactech implants in knee and ankle replacement procedures and to return any existing inventory of recalled devices. Exactech has been transparent about the issue, taking responsibility and acknowledging the problem in the letter.
For individuals who have undergone knee replacement surgery with an Exactech system, the recall letter advises consulting their doctors. Physicians have been urged to keep a record of all patients with Exactech implants and closely monitor them for any indications of potential insert failure.
Additionally, Exactech has supplied doctors with a sample letter to send to their patients, explaining the rationale behind the recall. If you are a recipient of this letter, the content should be similar to the information provided by the company’s lawyers.
Mass Tort Attorney Advises if you Want to be Included in the Exactech Recall Lawsuit
If you have an Exactech knee or ankle replacement implant, symptoms of potential insert failure may include pain and swelling, difficulty bearing weight on the joint, joint grinding, or knee/ankle instability. Surgeons are instructed to conduct X-rays if an implant failure is suspected in order to assess the condition of the Exactech implant. If everything matches the above, you must join the league of sufferers Exactech has raised.