Characterization of Spine Implant Device Recalls: A 21-Year Analysis.

Abstract

Observational epidemiological study. To identify and comprehensively assess reasons for recalls of spinal implant devices used in patients over the past 21 years. The number of spine implant devices on the market continues to rise. Although the Food and Drug Administration (FDA) regulates the safety of these devices, there is a paucity of literature on the reasons spine implant devices are recalled. The FDA device recall database was queried using the search term "spine" for recalls between 2003