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U.S. Department of Health and Human Services

Class 2 Device Recall UltraSeal XT Plus Clear Refill

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 Class 2 Device Recall UltraSeal XT Plus Clear Refillsee related information
Date Initiated by FirmNovember 17, 2016
Date PostedDecember 03, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall NumberZ-0704-2017
Recall Event ID 75796
510(K)NumberK993846 
Product Classification Sealant, pit and fissure, and conditioner - Product Code EBC
ProductUltraSeal 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.
Code Information Lot BD79T
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3800
For Additional Information Contact
801-553-4194
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionConsignees 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 in Commerce31
DistributionWorldwide Distribution - US Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EBC
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