FDA Says Exactech Hip, Knee, Ankle Devices Were Defectively Packaged
March 23, 2023
WASHINGTON, D.C. — The Food and Drug Administration has warned patients and doctors that many recalled Exactech joint replacement devices manufactured between 2004 and August 2021 were packaged in defective bags that failed to protect the devices from oxidation, which can cause degradation over time.
In a March 23 Safety Communication, the FDA explained that “oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery.”
“The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time,” …