3M ESPE Recalls Unitek Primary Stainless Steel Crowns for Defective Edges
3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.
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 defect involves incorrect manufacturing contours without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) due to a manufacturing defect. The affected products were manufactured with the incorrect marginal contour edge.
The recall includes product codes 902150 (Kit) and 900114 (Refill). Specific lot codes involved are N492036, N495695, N486012, and N483920. Lot codes N500930 and N497616 are noted as not distributed. The total quantity recalled is 3,409 crowns, distributed in the United States and Canada.
These stainless steel crowns are designed for long-term provisional coverage on adult molars and bicuspids, as well as pediatric posterior and anterior teeth. Consumers and healthcare providers should stop using the affected products and contact 3M ESPE for instructions on return or replacement.
The recalled product
- Product
- 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and…
- Manufacturer
- 3M Company/3m Espe Dental Products
- Category
- Medical Device — Dental Crowns
- Hazard
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 (2)
- Product Code 902150 (Kit) ¿ Lot codes N492036
- N497616 (not distributed) and N483920
Distribution
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