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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 July 08, 2011
Date Posted November 14, 2011
Recall Status1 Terminated 3 on June 28, 2013
Recall Number Z-0186-2012
Recall Event ID 60242
510(K)Number K060698  
Product Classification Cement, dental - Product Code EMA
Product Breeze Self-Adhesive Resin Cement, Part Number: N97A,


Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Code Information Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478
Recalling Firm/
Manufacturer		 Kerr/pentron Dba Kerr Corporation And Pentron Clinical
1717 W. Collins Ave
Orange CA 92867
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall		 Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
FDA Determined
Cause 2		 Pending
Action Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in Commerce 336 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
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
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