Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.
PMID: 42825233 ·
Lokeshwar S Bhenderu, Paras Gupta, Andrew Schindler, Shourya Kumar, Jesus G Cruz-Garza, Taimur Hassan, Alex Hoang, Gavin W Britz, Amir H Faraji, Kurt A Yaeger
Abstract
The neurosurgery landscape has witnessed substantial advancements in recent years, with an increasing reliance on medical devices to enhance surgical safety and efficacy. However, alongside this progress, there has been a rise in the number of device recalls, prompting a need for comprehensive analysis to understand the underlying trends and factors contributing to these recalls. This quantitative review aimed to analyze 2 decades of U.S. Food and Drug Administration (FDA) recall data within neu
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