Home / Recalls / Ultradent Products, Inc. / Z-0704-2017

Z-0704-2017 Class II Terminated

Recalled by Ultradent Products, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
December 14, 2016
Initiation Date
November 17, 2016
Termination Date
June 5, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

Lot BD79T

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