Recall Z-0455-2012 ยท EMA Cement, Dental
Kerr Corporation
Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining
| Date | Jan 11, 2012 (initiated Mar 3, 2011) |
| Status | Terminated |
| Reason | The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product. |
| Root cause | Nonconforming Material/Component |
| Action | Pentron Clinical sent an URGENT: Medical Device Recall letter dated April 20, 2011 to all affected customers. The letter described the product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all product(s) subject to recall for return and exchange at no charge. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were also asked to complete and return the enclosed Recall Return Form. Contact Pentron Clinical Customer Service at (800) 551-0283, (o |
| Quantity | 100 Units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.