Recall Z-0989-2012 ยท EBF Material, Tooth Shade, Resin
Sybron Dental Specialties
Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28
| Date | Feb 11, 2012 (initiated Mar 3, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. |
| Root cause | Nonconforming Material/Component |
| Action | Pentron Clinical sent an initial "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and fax back an enclosed recall return form in order to confirm their receipt of the recall notification. A second "URGENT: MEDICAL DEVICE RECALL" letter dated November 10, 2011 was sent to all affected customers because Pentron Clinical expanded the recall. On December 8, 2011 another recall communication was forwarded to all affected customers t |
| Quantity | 77,289 Units total |
| Distribution | Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052106 | SIMILE FLOW Pentron Clinical Technologies, Oct 31, 2005 |