Device product
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.
Z-0704-2017
Product summary
- Event
- Event 75796
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-0704-2017
Official wording
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.
Code information: Lot BD79T
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled