Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023.

Abstract

Orthopaedic devices constitute nearly 20% of all medical devices, with approximately 12% of implants recalled within 10 years of Food and Drug Administration (FDA) clearance. Class I recalls represent the FDA's highest level of concern, indicating that device use could result in serious injury or death. Despite their severity, class I orthopaedic device recalls have not been systematically characterized, and concerns remain regarding delayed responsiveness to safety signals. The FDA recall database was reviewed for class I medical device recalls from November 2002 to December 2023, and orthopaedic-related events were identified. Devices were categorized by subspecialty (arthroplasty, spine, other), authorization pathway (510(k) vs. Premarket Approval (PMA)), and recall cause. FDA-designated root causes were reclassified into clinically relevant categories. Annual Manufacturer and User-facility Device Experience files were reviewed for associated adverse event reports (AERs), and the interval between the earliest AER and formal recall was calculated. Statistical comparisons were made using the Fisher exact test and Mann-Whitney U test. Sixteen class I recall events affecting 20 orthopaedic devices were identified: 50% arthroplasty, 44% spine, and 6% other. Only 13% of recalled devices underwent PMA; the rest were 510(k)-cleared. Most recalls (69%) were due to intrinsic device design flaws. Surgeon consensus reached through reconciliation of differences on root cause-matched FDA categorization in only 30% of non-design-designated recalls. The median AER-to-recall interval was significantly longer for arthroplasty devices (5.8 years) than spine devices (1.8 years, P = 0.014). Most class I orthopaedic device recalls involved design flaws in 510(k)-cleared implants and were subject to notable delays between initial adverse reports and recall, particularly in arthroplasty implants. Discrepancies between FDA classifications and clinical judgment, as well as inconsistent recall labeling, highlight the need for more robust and specific postmarket surveillance. This includes collaboration with surgeons and potential linkages with existing registries, such as the American Academy of Orthopedic Surgeons' American Joint Replacement Registry, to facilitate early identification of problematic devices.