Home / Recalls / 3M Company/3m Espe Dental Products / Z-2100-2013

Z-2100-2013 Class II Terminated

Recalled by 3M Company/3m Espe Dental Products — Saint Paul, MN

Recall Details

Product Type: Devices
Report Date: September 4, 2013
Initiation Date: August 5, 2013
Termination Date: December 11, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3409 crowns (2949 US and 460 OUS)

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.

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.

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.

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