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Recall Observatory FDA recall evidence

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

November 17, 2016

Class II

Product summary

Firm
Ultradent Products, Inc.
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

    reason.labeling_packaging · v1.0.0

    mislabeled