Exactech Finally Initiates Recall of Equinoxe Shoulder Implants

Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA announced in an update of its Jan. 16 safety communication on the products.

The defective bags, affecting 124,231 units sold in the U.S. from 2004 to Feb. 15, were used to package the Equinoxe shoulder system and were missing one of the oxygen barrier layers that protects the devices from oxidation, according to the FDA. The agency said that “oxidation can lead to faster device wear or failure, and device component cracking or fracture. This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.”

The FDA issued the Jan. 16 safety communication after Exactech declined to initiate a voluntary recall for the implants. At that time, the FDA said it would continue to work with the company to evaluate “the risks of all joint devices that contain plastic components packaged in defective packaging and review information they provide regarding their joint replacement devices’ safety and effectiveness.”

Read the FDA safety communication here.

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