Reported Sep 4, 2013 · Terminated
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114…
3M Company/3m Espe Dental Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 3M Company/3m Espe Dental Products · Bldg 0260-02a-11 · Saint Paul, MN · 55144-0001
Is this the product you have?
- 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box)
- Product UsageStainless 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
- Lot codes and dates
- Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
- Amount recalled
- 3409 crowns (2949 US and 460 OUS)
Where it was sold
Why it was recalled
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
This product could cause temporary or reversible health problems — stop using it.
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