Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4) Recalled by 3M Company/3m Espe Dental Products Due to 3M ESPE is recalling Unitek Primary Stainless Steel...

Date: August 5, 2013
Company: 3M Company/3m Espe Dental Products
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 3M Company/3m Espe Dental Products directly.

Affected Products

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.

Quantity: 3409 crowns (2949 US and 460 OUS)

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About 3M Company/3m Espe Dental Products

3M Company/3m Espe Dental Products has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report