Recall Z-0186-2012 ยท EMA Cement, Dental
Kerr/pentron Dba Kerr Corporation And Pentron Clinical
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.
| Date | Nov 14, 2011 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Cust |
| Quantity | 336 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam. |
| 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 |