Mizuho OSI recalls HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Recall date

July 29, 2021

Source

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

Recall number

Z-1573-2022

FDA classification

Class II

Brand / firm

Mizuho OSI

Sold / distributed

U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

Why it was recalled

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

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

What was recalled

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144