Recall Z-1100-2012 ยท EMA Cement, Dental
Kerr Corporation
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.
| Date | Feb 24, 2012 (initiated Dec 2, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 622 units total (12 units in US) |
| Distribution | Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 Pentron Clinical Technologies, May 10, 2006 |