BioPro, Inc. recalls Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS…

Recall date

June 25, 2019

Source

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

Recall number

Z-2250-2019

FDA classification

Class II

Brand / firm

BioPro, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.

Why it was recalled

Manufacturing flaw in the sterile barrier system

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

What was recalled

Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine