FDA 483 - ConMed Corporation - September 22, 2020

An FDA inspection of ConMed Corporation in Utica, NY, a medical device manufacturer, revealed significant issues with their quality system. The firm failed to adequately investigate complaints related to device malfunctions, specifically concerning their AirSeal IFS medical device. Additionally, the company did not submit required Medical Device Report (MDR) reports within the mandated timeframe for malfunctions that could cause serious injury or death.