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

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.