Coltene Whaledent FG 57 Dental Burs Recalled for Packaging Error
Coltene Whaledent is recalling 556 FG 57 dental burs that were incorrectly packaged as FG 557 burs, which remove more material.
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 difference in material removal without reported injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Coltene Whaledent Inc is recalling 556 units of the FG 57 100057X dental bur. 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. The affected products were sold to distributors located in Florida, Nevada, Pennsylvania, Tennessee, and Texas, as well as distributed to Canada. The specific code for the affected units is J79552.
Consumers and distributors should stop using the affected burs and contact Coltene Whaledent Inc for further instructions.
The recalled product
- Product
- FG 57 100057X (100057X)
- Manufacturer
- Coltene Whaledent Inc
- Category
- Medical Device — Dental Burs
- 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)
- J79552
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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