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

Z-0704-2017 Class II Terminated

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

FDA device recall Z-0704-2017 was initiated by Ultradent Products, Inc. on November 17, 2016 and is designated Class II. 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 w… The recall status is terminated (terminated June 5, 2017). Affected quantity: 31.

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

Other recalls by Ultradent Products, Inc.

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  • Z-3067-2024 Class II — Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/C (August 2, 2024)
  • Z-3066-2024 Class II — Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog (August 2, 2024)
  • Z-3068-2024 Class II — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refil (August 2, 2024)
  • Z-1368-2022 Class II — Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-E (June 1, 2022)
  • Z-0053-2021 Class II — PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cur (August 31, 2020)
  • Z-0690-2019 Class II — Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Co (July 12, 2018)
  • Z-3218-2017 Class II — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ste (August 4, 2017)
  • Z-3215-2017 Class II — Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ste (August 4, 2017)
  • Z-3216-2017 Class II — Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ste (August 4, 2017)

FDA data resources