The defective bags used for packaging were missing an oxygen barrier layer that protects devices from oxidation, which can lead to faster device wear or failure and component cracking and fractures.
The wear could lead people with the device to need additional surgery to replace the system, according to the Jan. 16 FDA alert.
If a patient’s shoulder system is functioning well with no pain or symptoms, the FDA does not recommend taking action to remove a well-functioning device.
The agency is warning surgeons not to implant devices packaged in defective bags and to monitor patients who were implanted with systems manufactured between 2004 and August 2021 for potential device wear, failure or bone loss.
To date, Exactech has declined to initiate a voluntary recall of the Equinoxe Shoulder System implants packaged in the defective bags, according to the FDA.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
