Coltene Whaledent FG 57 Dental Burs Recalled Due to Packaging Error
Coltene Whaledent is recalling 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: This is a Class II recall involving a packaging error that could lead to improper use of the device, but no injuries or illnesses are reported in the source text.
Plain-English summary
Coltene Whaledent Inc is recalling 556 units of the Clinic Pack 100 Pieces FG 57 100057C dental burs. The recall is due to a packaging error where FG 557 burs were incorrectly packaged as FG 57 burs.
The hazard associated with this recall is that FG 557 burs remove more material than FG 57 burs. This discrepancy could lead to unintended removal of dental material during use.
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 manufacturer for instructions on return or replacement.
The recalled product
- Product
- Clinic Pack 100 Pieces FG 57 100057C (100057C)
- Manufacturer
- Coltene Whaledent Inc
- Hazard
- 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)
- J74027
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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