Home / Recalls / Ultradent Products, Inc. / Z-3067-2024

Z-3067-2024 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
August 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
560

Product Description

Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A

Reason for Recall

Due to a manufacturing issue, red particulates present in the expressed composite.

Distribution Pattern

US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES

Code Information

Lot Code: Model No 4817; UDI-DI 00883205033680; Lot Number C1464; Expiration Date 30-Jun-2026

Other recalls by Ultradent Products, Inc.

  • 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-3215-2017 Class II — Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ste (August 4, 2017)
  • Z-3214-2017 Class II — Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 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)
  • Z-3217-2017 Class II — Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ste (August 4, 2017)
  • Z-3218-2017 Class II — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ste (August 4, 2017)