Z-2100-2013 Class II Terminated
FDA device recall Z-2100-2013 was initiated by 3M Company/3m Espe Dental Products on August 5, 2013 and is designated Class II. 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. The recall status is terminated (terminated December 11, 2013). Affected quantity: 3409 crowns (2949 US and 460 OUS).
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