Exactech Shoulder Recall

Exactech Shoulder System Fails Due to Defective Packaging

The Equinoxe Shoulder System is a widely used medical device for treating shoulder injuries and painful shoulder-related conditions. Unfortunately, many of these devices were packaged in bags that did not provide adequate protection against oxidation, leading to potential issues with the system’s plastic component.

When oxygen reaches the polyethylene material before implantation, it can compromise the integrity of the device and increase the patient’s risk of complications.

Equinoxe Shoulder System implants are supposed to provide relief for adults suffering from painful shoulder conditions like osteoarthritis, osteonecrosis, and rheumatoid arthritis. These shoulder implants are also effective in cases where previous shoulder replacements have failed, provided there is adequate bone and soft tissue.

These devices, produced by Exactech, were packaged in defective bags from 2004 to August 2021. The defective packaging may cause thousands of patients to undergo revision surgeries for those with the implant.

Exactech has initiated many product recalls over the years, including defective hip implants, knee implants, and ankle implants. Now, the latest failure for Exactech is their shoulder implants.

Defective Packaging of Equinoxe Shoulder System Medical Devices

Many Equinoxe Shoulder System medical devices were packaged in faulty bags that lacked an essential oxygen barrier layer intended to protect the devices from oxidation. 

These defective bags allow oxygen to reach the plastic (polyethylene) component of the Equinoxe Shoulder System before it is implanted into a patient’s body.

If the Equinoxe Shoulder System’s plastic component is exposed to a significant amount of oxygen before implantation, it may undergo chemical changes due to oxidation. This chemical reaction of the plastic element over time can lead to:

• Early and extreme device wear

• Component fracture
• Device failure
• New or worsening pain
• Bone loss
• Swelling in the affected area
• Revision surgery as a result of these issues.

As a precautionary measure against potential health risks, Exactech has recalled specific Equinoxe Shoulder System joint replacement devices.

Exactech Equinoxe Shoulder Recall Updates

April 19, 2024

Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in defective bags from the facilities’ unused inventory. The Exactech shoulder implant recall is due to potential adverse reactions, including range of motion problems.

To see if your device is affected by the recall, visit Exactech’s recall information page.

Below are several U.S. Food and Drug Administration (FDA) recommendations.

January 16, 2024

The FDA warns patients and healthcare providers about potential health risks linked to the Equinoxe Shoulder System joint replacement devices. Manufactured by Exactech from 2004 to August 2021, these devices were packaged in defective bags.

The defective bags used for packaging the Equinoxe Shoulder System devices lacked an essential oxygen barrier layer. This layer is crucial as it protects the devices from oxidation—a reaction to oxygen exposure that can degrade or fracture parts over time.

The potential premature wear and tear of the device could require patients to undergo additional surgery to replace or repair the device.

 

Recommendations for Patients By the FDA

If your Equinoxe Shoulder System is working well and you are not experiencing any pain or symptoms, the FDA advises against surgery to remove a well-functioning device.

If you have an Equinoxe Shoulder System implanted and notice any new or worsening pain, swelling, difficulty using your arm, unusual noises, or weakness near the implant, please get in touch with your healthcare provider immediately.

How To Check If Your Exactech Shoulder Insert Has Been Recalled

Every Exactech shoulder implant has a unique device identifier (UDI) to help identify individual medical devices sold in the United States from manufacturing through distribution to patient use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database – Identify Your Medical Device
• Benefits of a UDI System

Check the UDI table below for the Equinoxe shoulder devices packaged in defective bags. The UDI is a unique code that includes a Device Identifier (DI), specifying the labeler and model, and a Production Identifier (PI), providing details like lot number, serial number, expiration date, and manufacture date.

FDA Action 

Click to view chart of recalled UDI

How to Determine If Your Exactech Shoulder Insert is Recalled

If you have your serial number, you can use Exactech’s recall serial number checker to see if the recall affects your shoulder liner. Enter all the numbers, including any zeros, as prompted by the system.

Even if your shoulder component is part of the recall, it doesn’t necessarily mean you will need surgery to remove the device. The FDA advises against surgery for patients with a well-functioning device without new or worsening pain or symptoms.

Filing an Equinoxe Shoulder System Lawsuit for Your Defective Medical Device 

If you have a problem with your device, seek medical attention from your orthopedic surgeon.

Then, call The Yost Legal Group to learn more about filing an Exactech shoulder implant lawsuit. The Exactech shoulder recall is due to potential shoulder implant failure. Taking legal action against manufacturers that produce defective medical devices helps to hold them accountable for their actions.

Filing a lawsuit for a defective Equinoxe Shoulder System is vital in holding manufacturers accountable for putting patients at risk due to negligent practices.

How The Yost Legal Group Can Help

If you have experienced any adverse medical issues with your Exactech shoulder implant, it is crucial to seek legal guidance from The Yost Legal Group. Our defective medical device lawyers have extensive experience handling cases involving defective medical devices.

We will work diligently to help you seek compensation for any injuries or damages you may have incurred. Contact us today for a free case evaluation, and let us fight for justice on your behalf.

Filing an Exactech shoulder lawsuit for a defective medical device can be complex and challenging. Having an experienced Exactech shoulder lawyer can make all the difference.

Our Exactech shoulder implant lawyers are dedicated to advocating for patients harmed by negligent manufacturers and holding them accountable for their actions.

We understand the intricacies of product liability law. We will work tirelessly to ensure you receive fair compensation for any injuries or damages caused by a faulty Equinoxe Shoulder System.

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