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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 Cementsee related information
Date Initiated by FirmJuly 08, 2011
Date PostedNovember 14, 2011
Recall Status1 Terminated 3 on June 28, 2013
Recall NumberZ-0186-2012
Recall Event ID 60242
510(K)NumberK060698 
Product Classification Cement, dental - Product Code EMA
ProductBreeze 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
ActionPentron 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 Commerce336 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EMA
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