Recall Z-2100-2013— 3M Company/3m Espe Dental Products
Class II · Terminated
Class II FDA medical device recall by 3M Company/3m Espe Dental Products, initiated 2013-08-05, terminated 2013-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge..
- Recalling firm
- 3M Company/3m Espe Dental Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-05
- Terminated
- 2013-12-11
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.