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U.S. Department of Health and Human Services

Class 2 Device Recall Breeze SelfAdhesive Resin Cement

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  Class 2 Device Recall Breeze SelfAdhesive Resin Cement see related information
Date Initiated by Firm December 02, 2010
Date Posted February 24, 2012
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1100-2012
Recall Event ID 61235
510(K)Number K060698  
Product Classification Cement, dental - Product Code EMA
Product Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
Code Information Lot # 200466
Recalling Firm/
Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
Manufacturer Reason
for Recall
The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.
FDA Determined
Cause 2
Nonconforming Material/Component
Action An "Urgent Medical Device Recall" letter was sent on 12/17/2010 via USPS 1st class mail to all their customers. The letter provides the customers with an explanation of the problem identified and the action to be taken. Customers were instructed to complete and fax back the enclosed recall return form. Customers with questions were instructed to call (800) 551-0283.
Quantity in Commerce 622 units total (12 units in US)
Distribution Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
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.
510(K) Database 510(K)s with Product Code = EMA and Original Applicant = PENTRON CLINICAL TECHNOLOGIES