3M Company/3m Espe Dental Products: Medical Device Recall in 2013 - (Recall #: Z-2100-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: August 5, 2013

Date Posted: September 4, 2013

Recall Number: Z-2100-2013

Event ID: 65913

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.

Status: Terminated

Product Quantity: 3409 crowns (2949 US and 460 OUS)

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated