Coltene Whaledent Inc recalls Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from…

Recall date

April 13, 2018

Source

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

Recall number

Z-1883-2018

FDA classification

Class II

Brand / firm

Coltene Whaledent Inc

Sold / distributed

The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada

Why it was recalled

The products are labeled with an incorrect product number.

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

What was recalled

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.