Medtronic Navigation, Inc. recalls Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

Recall date

October 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0658-2020

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jers…

Why it was recalled

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517