The Recall Desk
LowFDA (Devices)·Z-1883-2018·Announced 2018-05-23

Coltene Whaledent Recalls Carbide Burs Due to Incorrect Product Number Labeling

Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a labeling error (incorrect product number) with no reported injuries or illnesses, fitting the criteria for cosmetic defects or documentation issues.

Plain-English summary

Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702. These rotary cutting devices are made from carbon steel or tungsten carbide and are intended to cut hard structures in the mouth, such as teeth or bone.

The recall was initiated because the products are labeled with an incorrect product number. The affected batch is identified as Batch I37640.

The products were distributed to New York and Canada. Consumers and healthcare providers should stop using the affected burs and contact Coltene Whaledent Inc for further instructions.

The recalled product

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.
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch I37640

Distribution

Distributed in 1 state: