Recall Z-1883-2018— Coltene Whaledent Inc

Name: FDA recall Z-1883-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-13

Class II · Terminated

Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2018-04-13, terminated 2019-04-08. FDA's recall record names no specific 510(k) clearance for this event. 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: The products are labeled with an incorrect product number..

Recalling firm: Coltene Whaledent Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-13
Terminated: 2019-04-08
Firm location: Cuyahoga Falls, OH, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.