Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging
Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.
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, and the hazard involves a functional discrepancy (excessive material removal) without reported injuries or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Coltene Whaledent Inc is voluntarily recalling 556 units of Strauss 25 Carbide Dental Burs (100057XXV). The recall is due to a packaging error where the FG 557 bur was incorrectly packaged as the FG 57 bur.
The hazard associated with this recall is that the FG 557 burs will remove more material than the FG 57 burs. This discrepancy could lead to unintended clinical outcomes if the incorrect bur is used.
The affected products were sold to distributors located in Florida, Nevada, Pennsylvania, Tennessee, and Texas, as well as distributed to Canada. Consumers and dental professionals should stop using the affected burs and contact the recalling firm for further instructions.
The recalled product
- Product
- Strauss 25 Carbide Dental Burs (100057XXV)
- Manufacturer
- Coltene Whaledent Inc
- Affected units
- 556
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)
- J77147 J93636
Distribution
Part of a larger recall action
This product is one of 5 recalled by Coltene Whaledent Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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