| Class 2 Device Recall Breeze SelfAdhesive Resin Cement |  |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = EMA
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