Exactech, Inc. recalls Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Recall date

October 25, 2016

Source

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

Recall number

Z-0900-2017

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Sw…

Why it was recalled

Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

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 Reverse Shoulder Fixed Angle Torque Defining Screw Kit