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U.S. Department of Health and Human Services

Class 2 Device Recall 3M ESPE Unitek Primary Stainless Steel Crowns

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  Class 2 Device Recall 3M ESPE Unitek Primary Stainless Steel Crowns see related information
Date Initiated by Firm August 05, 2013
Date Posted August 27, 2013
Recall Status1 Terminated 3 on December 11, 2013
Recall Number Z-2100-2013
Recall Event ID 65913
Product Classification Crown, preformed - Product Code ELZ
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.
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
Recalling Firm/
Manufacturer		 3M Company/3m Espe Dental Products
Bldg 0260-02a-11
Saint Paul MN 55144-0001
For Additional Information Contact William J Donovan
800-634-2249
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 3M ESPE sent a 3M "Voluntary Recall" letter dated August 1, 2013 to all affected customers. Separate letters were addressed to distributors and doctors. The letters described the product affected by the recall, problem and actions to be taken. The doctors were advised to complete the attached inventory checklist and call the 3M ESPE Dental Products Customer Care Center at 1-800-634-2249. Select option #1 to arrange for return and replacement of your product. Distributors were advised to quarantine and return the product and not to further distribute it. For product return they should contact 3M ESPE Dental Products Customer Service at 1-800-237-1650. If the product was further distributed they ask that they inform them of the recall. A letter was prepared that can be used for their communication to customers. for additional questions they should contact 651-733-7767.
Quantity in Commerce 3409 crowns (2949 US and 460 OUS)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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