Coltene Whaledent Inc: Medical Device Recall in 2018 - (Recall #: Z-1883-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 13, 2018

Date Posted: May 23, 2018

Recall Number: Z-1883-2018

Event ID: 79994

Reason for Recall:

The products are labeled with an incorrect product number.

Status: Terminated

Product Quantity: 11

Code Information:

Batch I37640

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated