Risk of Recall Among Plastic Surgery Devices Cleared Through the FDA 510(k) Pathway
Abstract
Background: The FDA 510(k) pathway is the predominant route by which medical devices reach the US market. Previous studies have examined recall risk across broad FDA panels, but none have characterized plastic surgery devices or compared recall patterns across subcategories within the field.
Objectives: The aim of this study was to determine the rate and severity of FDA recalls among 510(k)-cleared plastic surgery devices, compare recall risk across subcategories, and benchmark against all other 510(k) devices.
Methods: All 510(k)-cleared devices (2008-2023) were obtained from the FDA premarket notification database. Two reviewers classified 234 surgery panel product codes, identifying 103 plastic surgery codes (3194 devices) in 8 subcategories. Each device was matched to the FDA recall database by its 510(k) number. All remaining 510(k) devices (n = 45,182) served as comparator. Recall rates were compared using χ2 tests and risk ratios (RR); time to first recall was modeled with Cox proportional hazards regression with Bonferroni correction.
Results: Of 3194 plastic surgery devices, 197 (6.2%) were recalled, including 11 Class I recalls (0.3%). The recall rate for all other 510(k) devices was 11.4% (RR, 0.54; 95% CI, 0.47-0.62; P < .001). After Bonferroni correction, 4 subcategories had elevated recall hazard vs lasers and energy: implants and fixation (hazard ratio [HR], 3.64), negative pressure wound therapy (HR, 2.53), surgical mesh and acellular dermal matrices (HR,…
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