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U.S. Department of Health and Human Services

Class 3 Device Recall 3M Unitek" Primary Stainless Steel Crowns

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  Class 3 Device Recall 3M Unitek" Primary Stainless Steel Crowns see related information
Date Initiated by Firm June 05, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on December 11, 2013
Recall Number Z-0428-2014
Recall Event ID 66509
Product Classification Crown, preformed - Product Code ELZ
Product 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns

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 N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
For Additional Information Contact
800-237-1650
Manufacturer Reason
for Recall		 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.
FDA Determined
Cause 2		 Process control
Action 3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-800-634-2249. For questions regarding this recall call 651-733-5718.
Quantity in Commerce 1419 (1325 US, 94 OUS)
Distribution Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
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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