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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

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.
Recall Number Z-2100-2013
Classification Class II
Code Info Product Code 902150 (Kit) · Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) · Lot Codes N486012, N497616 (not distributed) and N483920
Product Distributed Qty 3409 crowns (2949 US and 460 OUS)
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.

Event Detail

Event Id 65913
Product Type Devices
Status Ongoing
Recalling Firm 3M Company/3m Espe Dental Products
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public Letter
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.
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