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2002年から2023年までの骨科医療機器の高リスク回収の特徴と時間遅れ

PMID: 41453025 · 2025-12-12

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学術誌The Journal of the American Academy of Orthopaedic Surgeons

年2025-12-12

PMID41453025

抄録

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

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