PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 23, 2018 Initiated: April 13, 2018 #Z-1883-2018

Product Description

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.

Details

Recalling Firm
Coltene Whaledent Inc
Units Affected
11
Distribution
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Location
Cuyahoga Falls, OH

Frequently Asked Questions

What product 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.. Recalled by Coltene Whaledent Inc. Units affected: 11.
Why was this product recalled?
The products are labeled with an incorrect product number.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1883-2018.