Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024).

Abstract

Current reliance on the expedited 510(k) approval pathway has driven rapid commercial availability of novel arthroscopic devices. Despite the low complication rates of arthroscopic procedures, products from this pathway are suspected to increase the rate of recalls and device malfunctions. This study aimed to characterize arthroscopic device recalls, analyze trends in recall incidence, and identify predictors of time to recall. A 20-year, retrospective, cross-sectional study was conducted using