An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.

Abstract

Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devi