FDA recall Z-1883-2018

Product

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.

Reason for recall

The products are labeled with an incorrect product number.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-04-13

Report date

2018-05-23

Termination date

2019-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cuyahoga Falls, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2018