Biomet 3i, LLC recalls Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements fo…

Recall date

November 16, 2015

Source

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

Recall number

Z-0564-2016

FDA classification

Class II

Brand / firm

Biomet 3i, LLC

Sold / distributed

Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.

Why it was recalled

Images contained within radiographic transparency ART 1036 are undersized.

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

What was recalled

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.