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 datab