Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process.

Abstract

Introduction The medical device industry has grown substantially in recent years. There is limited research examining orthopedic subspecialties and the recall of orthopedic devices. We hypothesize that knee arthroplasty devices cleared through the Food and Drug Administration (FDA) 510(k)-notification process would have a higher recall rate than the premarket approval (PMA) process. Methods The FDA database was thoroughly queried for all knee arthroplasty surgical devices from January 1, 2007 th