Exactech, a company that makes joint replacements, has officially recalled its Shoulder System devices after a U.S. Food and Drug administration (FDA) complaint about damage and wear to the devices as a result of inefficient packaging.
The FDA initially made the complaint in January, at which time Exactech declined to remove the affected products from the market. On April 19, the FDA announced the company changed its stance and will be recalling some, specifically devices used in knee and shoulder replacements. The full list of recalled items can be found here.
In March, Exactech in a letter acknowledged the FDA's concerns and said it would be recalling some products in compliance with the safety warning. The recall affects several Exactech devices manufactured between 2004 and 2021.
In its warning, the FDA advises surgeons against using the devices, citing chemical oxidation of the plastic components over time, which could result in device failure, severe injury to patients, and possibly a need for a second joint replacement.
Despite the risks, the FDA recommends patients who currently have the devices implanted be monitored and not rush to remove them, as not all of the artificial joints will fail.
“Based on currently available information, the FDA does not recommend removal of well-functioning Equinoxe Shoulder Systems from patients who do not have any new or worsening pain or symptoms,” the safety notice reads.
The FDA then asks providers to 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,” suggesting they perform “X-rays to further evaluate the patient and their implanted device if you suspect a failed device.”
The full FDA warning letter with recalled product numbers and instructions on how to report problems with these devices can be read here.
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