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Terminated

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.

FDA Recall Z-0704-2017 · Posted 2016-12-03

Recalling FirmUltradent Products, Inc.
Recall StatusTerminated
Product CodeEBC
Date Initiated2016-11-17
Date Terminated2017-06-05
Product Quantity31

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993846ULTRASEAL XT PLUSUltradent Products, Inc. · 2000-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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