In a recent development, Exactech, a renowned medical device company, has initiated a recall of its Equinoxe Shoulder System devices. This recall comes in the wake of a warning issued by the FDA highlighting alarms over the packaging of this system, indicating that defects may lead to significant health risks for patients.
Exactech has unfortunately found itself no stranger to controversy in recent years. The company has faced hundreds of lawsuits concerning various joint implants, including ankles, knees, and hips. These legal battles have shed light on issues ranging from device failure to adverse patient reactions, with a common denominator remaining the same: flawed components compromising patient safety. This recurring theme underscores the imperative for rigorous quality control measures within the medical device industry.
The Equinoxe Shoulder System Recall:
In January 2024, the FDA issued a warning regarding Exactech’s Equinoxe Shoulder System implants, highlighting significant safety concerns. The warning drew attention to defective packaging, raising alarms about the integrity of the shoulder joint implants. Specifically, it was discovered that certain implants produced between 2004 and 2021 lacked a crucial oxygen barrier layer in their packaging. This layer is essential for shielding the implants from oxidation, a chemical process capable of degrading the plastic within the implant itself. As a result, patients who have received these implants may experience accelerated deterioration, possibly necessitating corrective surgery.
Potential Health Risks
Oxidation of the plastic component over time can result in the risk of:
- Early and excessive device wear
- Component fracture
- Device failure
- New or worsening pain
- Bone loss
- Swelling in the affected area
This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.
The FDA strongly advises individuals with symptoms such as pain, swelling, or other issues related to their Exactech shoulder implant to promptly consult their healthcare provider. Additionally, healthcare providers are urged to closely monitor patients who have undergone implantation of the Equinoxe Shoulder System between 2004 and 2021. Early detection of any complications is crucial for ensuring timely intervention and optimal patient outcomes.
What are Equinoxe Shoulder System?
The Equinoxe Shoulder System, which is sold by Exactech, is a medical device used in adults to replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue present.
Legal Implications
If you or a loved one has experienced adverse effects or complications due to the Exactech Equinoxe Shoulder System, you may be entitled to legal recourse. Manufacturers have a duty to ensure the safety of their products, and when they fall short, legal action becomes a crucial avenue for seeking justice.
Steps to Take if Affected:
- Seek Medical Attention: If you are experiencing any symptoms or complications associated with the Exactech Equinoxe Shoulder System, it is imperative to seek immediate medical attention.
- Document Everything: Keep detailed records of your medical treatments, symptoms, and any communication with healthcare professionals regarding the issues you are facing.
- Consult Legal Professionals: Reach out to a personal injury lawyer with experience in defective product cases. They can evaluate your situation, provide guidance on your legal options, and help you navigate the complexities of filing a claim.
Why Choose Meyers-Flowers for Your Defective Exactech Device?
As a top tier law firm, Meyers & Flowers has decades of experience pursuing large corporate medical device companies. Exactech has the responsibility of providing safe, reliable devices to the public and failing to do this bears the consequences. Unfortunately getting proper compensation from large corporations requires forceful application of the laws covering negligence and personal injury.
Our attorneys have obtained millions of dollars for our clients both in settlement negotiations and high dollar awards at trial. We have a formidable team of professionals who relentlessly prepare every case for trial, showing the opposition that we are prepared and will succeed before a jury. Our expertise in successfully prosecuting those responsible for releasing defective medical devices and harmful drugs is well known; we are fully able to litigate a successful lawsuit throughout the United States.
Contact us today for a free case evaluation online or by phone at (630) 576-9696. No fee unless we win or settle your case.