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 bicuspids as well as pediatric posterior and anterior teeth.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 3M Company/3m Espe Dental Products
- Reason for Recall:
- 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 bicuspids as well as pediatric posterior and anterior teeth.
Product Codes/Lot Numbers:
Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2100-2013
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Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..