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
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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/ Manufacturer |
Kerr Corporation 1717 W Collins Ave Orange CA 92867-5422
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For Additional Information Contact | 714-516-7400 |
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 |
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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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