Exactech Recalls Equinoxe Shoulder System Devices With Defective Packaging
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In response to potential health risks, Exactech has initiated a recall to remove certain Equinoxe Shoulder System joint replacement devices from facilities’ unused inventory.
Exactech manufactured the devices affected by the recall and packaged them in defective bags between 2004 and August 2021. The defective packaging could lead people with the device to need revision surgery to replace or correct the implant.
“The defective bags used to package the Equinoxe Shoulder System devices were missing one of the oxygen barrier layers that protect the devices from oxidation, a chemical reaction with oxygen that can degrade plastic components over time,” according to the U.S. Food and Drug Administration. “Oxidation can lead to faster device wear or failure, and device component cracking or fracture.”
The FDA announced the recall on April 19, 2024, roughly three months after the agency had warned about risks with the Exactech Equinoxe Shoulder System with defective packaging.
Exactech had initially declined to initiate a recall of the Equinoxe Shoulder System implants packaged in the defective bags, despite FDA safety alerts regarding these and other Exactech joint replacement devices.
Exactech Lawsuits Follow Recalls, Device Complications
The FDA alerted patients and health care providers about potential health risks associated with the Equinoxe Shoulder System joint replacement devices on Jan. 16, 2024. Ten months prior, the agency issued a safety communication to remind patients of similar issues with Exactech knee, ankle and hip devices.
Between June and August 2021, Exactech recalled about 533,160 hip, knee and ankle devices because of defective packaging. The FDA classifies the Exactech recalls as Class II, which means these recalled devices may cause serious injury or temporary illness.
Patients who had hip, knee or ankle surgery using a recalled Exactech device and have experienced severe complications may be eligible to file an Exactech lawsuit against the company. As of April 2024, plaintiffs had filed over 1,400 federal lawsuits.
How To Check If Your Exactech Shoulder Insert Has Been Recalled
If you know your serial number, you can use Exatech’s recall serial number checker to see if the recall affects your shoulder liner. The system will prompt you to enter all numbers, including any zeros.
If your shoulder component is within the scope of the recall, it does not automatically mean you need surgery to remove the device. The FDA does not recommend surgery to remove a well-functioning device from patients with no new or worsening pain or symptoms.
However, 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.
The FDA encourages patients to report suspected device problems through the MedWatch Voluntary Reporting Form. You can also call 1-800-332-1088 for more information on how to mail or fax the form.