PubMed

FDA 회수된 힘줄置换 장비의 트렌드 분석: 후향적 검토

PMID: 41947919 · 2026-04-09

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학술지JB & JS open access

연도2026-04-09

PMID41947919

초록

Hip arthroplasty implants are classified as Class III medical devices by the US Food and Drug Administration (FDA), requiring rigorous evaluation to ensure safety and efficacy. While these standards aim to ensure safety, device recalls remain an essential component of postmarket surveillance to address unforeseen performance issues. The objective of this study was to characterize the frequency, causes, and regulatory origins of FDA-recalled hip arthroplasty implants, identifying trends in device

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