PubMed

Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017.

PMID: 33339030 · 2020-11-01

W, e, s, l, e, y, , P, e, t, e, r, s, ;, , C, a, r, l, , P, e, l, l, e, r, i, n, ;, , C, o, r, y, , J, a, n, n, e, y

RevistaBiomedical instrumentation & technology

Año2020-11-01

PMID33339030

Resumen

Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. The FDA's dev

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