Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Recall date

April 13, 2022

Source

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

Recall number

Z-1247-2022

FDA classification

Class II

Brand / firm

Medacta Usa Inc

Sold / distributed

Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.

Why it was recalled

A Size 2 trial baseplate was assembled with Size 1 instrument sets.

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

What was recalled

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1