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 and 2024. Data were collected regarding recall class, recall reason, FDA 510(k)/premarket approval decision date, product manufacturer, and device indication. The data was then reviewed to identify recalls for spine implant devices. A total of 386 spine implant devices were identified between January 2003 and December 2024. Among all recalls classified, 3.4% (n=13) were class I, 88.1% (n=340) were class II, and 8.5% (n=33) were class III. The most common reasons for recall were "Device/Component design" (52.8%) and "Packing/Processing Control" (24.1%). The median number of devices recalled by manufacturers included in the study was two with the highest being 41 devices. Overall, 76.9% of spine implant recalls reviewed were primarily due to issues with device design and processing control. 88.1% of recalls were classified with a class II FDA designation. This is the first study to present a retrospective regulatory analysis of FDA spine implant recalls and highlights the importance of premarket analysis and postmarketing surveillance to improve device safety. 4.