One More Out: Exactech Announced the Recall of Equinoxe Shoulder System

by | May 20, 2024 | Exactech Recall

Exactech recall lawsuits

The last update about Exactech is that the company initiated a voluntary recall at the end of April for its Equinoxe Shoulder System joint replacement devices. This is due to the ongoing issues with defective packaging affecting people and causing faster wear of the device. 

This recall affects devices packaged between 2004 and August 2021 and involves devices sealed in bags that lack an essential oxygen barrier that protects them from oxidation, according to the U.S. Food & Drug Administration (FDA). This causes components of the Exactech devices to degrade and fail, leading patients to extra surgeries to remove implants. 

“If your Equinoxe Shoulder System is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove a well-functioning device,” the FDA stated. The Agency also advised that Equinoxe Shoulder System patients who experience symptoms like pain, swelling, grinding, or weakness near the implant zone need to contact their healthcare providers as soon as possible.

The Legal Repercussions Exactech Faces

The FDA issued a safety communication in January to patients and healthcare providers warning about the issues after Exactech failed to issue a recall of its devices until April when the company announced that it would recall its devices and remove unused inventory. 

This sparked more than 1,400 Exactech recall lawsuits filed by patients seeking compensation for their injuries and damage. The lawsuits claim that these defective parts caused pain, stiffness, device failure, and other problems that led to revision surgery, limited range of motion, and even bone loss (Osteolysis).

Currently, these lawsuits are consolidated in multidistrict litigation (MDL) in New York. At this point, there have been no trials. Lawyers are still taking clients and evaluating their cases. If you are having issues with these devices, having the help of a Mass Tort Attorney like the ones we have here at People for Law will help you.

What the FDA Recommends to Patients and Providers 

The FDA already issued in January what patients and health care providers can do if they have an Exactech device: 

Recommendations for Patients:

  • If your Equinoxe Shoulder System is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove a well-functioning device.
  • Contact your health care provider if you have an Equinoxe Shoulder System implanted and you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device.

Recommendations for Health Care Providers:

  • Do not implant any Equinoxe Shoulder Systems packaged in defective bags.
  • Based on currently available information, the FDA does not recommend the removal of well-functioning Equinoxe Shoulder Systems from patients who do not have any new or worsening pain or symptoms.
  • Monitor patients who have an implanted Equinoxe Shoulder System manufactured by Exactech between 2004 and August 2021 for potential device wear, failure, or bone loss. Consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device.
  • Discuss revision surgery with patients who may have worsening pain or joint weakness that is potentially attributable to the device based on a clinical examination on a case-by-case basis. As a part of shared decision-making, discuss the benefits and risks of all relevant treatment options with your patients.

If you suffered any complications from an Exactech Device, the first thing you need to do is to schedule an appointment with your doctor even if you received a recalled implant, regardless of any current problems. Monitoring is essential to evaluate further complications.

Exactech offers compensation to those affected by their recalled implants. However, signing any document with the company may prevent you from filing a claim against them. That is why you should contact a Mass Tort Attorney who will review your case and give you legal advice on how to proceed with your claim.

Contact your Mass Tort Attorney

Seeking legal advice is crucial to understanding your rights and options in this situation. Here at People for Law, our commitment is to protect your rights and help you achieve the compensation you deserve, and we will work tirelessly to achieve it.