Análise de Tendências em Dispositivos de Artroplastia de Quadril Retirados pela FDA: Uma Revisão Retrospectiva.
PMID: 41947919 ·
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Resumo
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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