Coltene Recalls Diatech Diamond Dental Burs Due to Length Variations
Coltene is recalling a specific lot of Diatech diamond dental burs because the instruments in the batch vary in length despite having the same shape and grit.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a manufacturing inconsistency (length variation) without reporting any injuries, illnesses, or specific safety hazards like breakage or contamination. This aligns with a moderate severity for a product defect where harm is not explicitly reported.
Plain-English summary
Coltene /Whaledent AG is recalling a single batch of Diatech Diamond dental burs, model 856-016-7-F, Round end taper. The affected units are identified by Lot/Batch Number J22952. The recall involves 20 units, with each unit containing 5 burs.
The reason for the recall is that the diamond burs in this specific batch contain instruments with the same grit size (fine) and shape (round end taper) but different lengths. This inconsistency in length within a single batch is the defect being addressed.
The distribution pattern is listed as GA (General Availability). Consumers and dental professionals who have purchased or received this specific lot of Diatech diamond burs should stop using them and contact the recalling firm, Coltene /Whaledent AG, for instructions on how to proceed.
The recalled product
- Product
- DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
- Manufacturer
- Coltene /Whaledent AG
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)
- Lot/Batch Number J22952
Distribution
Distributed in 1 state:
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