Coltene Whaledent Recalls CEI Cutting Edge Instruments Due to Packaging Error
Coltene Whaledent is recalling 556 CEI Cutting Edge Instruments (PTC-57C) because FG 557 burs were incorrectly packaged as FG 57 burs, which may 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 packaging error that could lead to excessive material removal, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Coltene Whaledent Inc is recalling 556 units of CEI Cutting Edge Instruments (PTC-57C). The recall was initiated because FG 557 burs were incorrectly packaged as FG 57 burs.
The hazard is that FG 557 burs will remove more material than FG 57 burs. The affected products were sold to distributors located in Florida, Nevada, Pennsylvania, Tennessee, and Texas, as well as distributed to Canada.
Consumers and distributors should stop using the affected products and contact the recalling firm for instructions on how to return them.
The recalled product
- Product
- CEI Cutting Edge Instruments (PTC-57C)
- 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)
- J88954
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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