Coltene Whaledent Recalls Mispackaged Alpen Clinic 100 Carbide Instruments
Coltene Whaledent Inc is recalling 556 packs of Alpen Clinic 100 Carbide Instruments because FG 557 burs were incorrectly packaged as FG 57 burs.
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 does not report any injuries or illnesses. The hazard is a packaging error leading to potential over-removal of material, which fits the criteria for a moderate severity recall involving low-risk contamination or minor errors without reported harm.
Plain-English summary
Coltene Whaledent Inc is recalling 556 packs of Alpen Clinic 100 Carbide Instruments (R100057C). The recall was initiated because FG 557 burs were incorrectly packaged as FG 57 burs.
The source text notes that FG 557 burs will remove more material than FG 57 burs. This mispackaging could lead to unintended removal of material during use.
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 items is J75023. Consumers and distributors should stop using the affected instruments and contact the recalling firm for instructions.
The recalled product
- Product
- Alpen Clinic 100 Carbide Instruments (R100057C)
- 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)
- J75023
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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