Innomed, Inc. recalls INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

Recall date

March 7, 2024

Source

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

Recall number

Z-1753-2024

FDA classification

Class II

Brand / firm

Innomed, Inc.

Sold / distributed

FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada

Why it was recalled

54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.

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

What was recalled

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup