Equinoxe Cage recalled over labeling errors

Recall date

August 31, 2017

Source

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

Official notice title

Exactech, Inc. recalls Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mat…

Recall number

Z-0414-2018

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland

Why it was recalled

Potentially mislabeled.

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

What was recalled

Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.