Recall Z-0704-2017 ยท EBC Sealant, Pit And Fissure, And Conditioner
Ultradent Products, Inc.
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
| Date | Dec 3, 2016 (initiated Nov 17, 2016) |
| Status | Terminated |
| Reason | There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T. |
| Root cause | Labeling mix-ups |
| Action | Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220. |
| Quantity | 31 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993846 | ULTRASEAL XT PLUS Ultradent Products, Inc., Feb 16, 2000 |