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

Abstract

Study design: Observational epidemiological study.

Objective: To identify and comprehensively assess reasons for recalls of spinal implant devices used in patients over the past 21 years.

Summary of background data: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Level of evidence: 4.