The U.S. Food and Drug Administration (FDA) issued a safety communication regarding possible risks related to Equinoxe shoulder system devices that were packaged in defective bags.
 
The agency reported the defective bags were missing an oxygen barrier layer that protects the shoulder replacement implant from oxidation, which can degrade polyethylene over time. Oxidation can lead to faster device wear or failure, as well as component cracking or fracture, each possibly leading to further surgeries to replace or correct the Equinoxe implant.
 
Patients were advised not to seek surgery if their Equinoxe shoulder is functioning well and they don’t have pain or symptoms, and to monitor for possible symptoms of implant wear and tear with their doctor. Clinicians were advised to monitor their patients and only act should they present with worsening symptoms.
 
To date, Exactech declined to begin voluntary recall for Equinoxe shoulder implants packaged in the defective bags. The agency said it’s working with Exactech to evaluate 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.
 
The FDA also released a safety communication on March 23, 2023, about a similar issue with other Exactech knee, ankle, and hip replacement devices.
 
Equinoxe shoulder implants are used in adults to replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or loss of normal structure and function. They’re also used to improve previously failed shoulder replacement devices when adequate bone and soft tissue are present.