3M Recalls Unitek Stainless Steel Crowns Due to Mislabeling
3M is recalling specific lots of Unitek Primary Stainless Steel Crowns because LL3 crowns were incorrectly labeled as UR4 crowns.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding crown type, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
3M Company - Health Care Business is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns. The recall involves Product Code 902150 (Kit) with Lot Codes N484233 and N463186, and Product Code 900224 (Refill) with Lot Codes N466509 and N473723.
The reason for the recall is that the Series UR4 crowns contain LL3 crowns which are incorrectly labeled as UR4 crowns. This is a labeling error regarding the specific type of crown included in the packaging.
A total of 1,419 units were distributed, including 1,325 in the US and 94 outside the US. Distribution included the US states of Indiana, Texas, Pennsylvania, Florida, Nevada, South Carolina, and Tennessee, as well as Canada and Saudi Arabia. Consumers and healthcare providers should check their inventory for these specific lot codes and contact 3M for instructions on how to return the affected products.
The recalled product
- Product
- 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
- Manufacturer
- 3M Company - Health Care Business
- Category
- Medical Device — Dental Crowns
- Hazard
Distribution
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