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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Manufacturer
- Coltene Whaledent Inc
- Hazard
- 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:
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