CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report

3M ESPE Unitek Primary Stainless Steel Crowns recalled

3M Company/3m Espe Dental Products is recalling 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), distributed nationwide in the US. The recall was initiated on 5 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920

Quantity recalled3409 crowns (2949 US and 460 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2100-2013
FDA event ID: 65913
Recalling firm: 3M Company/3m Espe Dental Products, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 5 Aug 2013
FDA classified: 27 Aug 2013
Reported: 4 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

5 Aug 2013	Recall initiated by company
27 Aug 2013	Classified by FDA	+22 days
4 Sep 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Florida Georgia Iowa Indiana Missouri New Jersey Nevada New York Pennsylvania South Carolina Tennessee Texas Washington

Questions about this recall

Why was it 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.

Which lots are affected?

Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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