FDAFDA · Food and drugs·Recall number Z-2100-2013
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.
Published September 4, 2013 · Recall initiated: August 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3M Company/3m Espe Dental Products
- Distributor
- Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.
- Lot
- Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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