Home / Recalls / Ultradent Products, Inc. / Z-1368-2022

Z-1368-2022 Class II

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

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
June 1, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1331 Kits (5009 Syringes)

Product Description

Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.

Reason for Recall

SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, Maine and the countries of Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, Greece.

Code Information

REF/ UDI-DI/ Lot: 4541/ 00883205104274/ BLRCR, BM1Y7, BM9G3; 4554/ 00883205104281/ BLSGH, BM578, BN449; 5135/ 00883205104311/ BLX3F, BLSGM, BLXSG, BLXW4, BM34M, BM784, BM9KB, BMJVK, BMTZM; S4554/ 00883205102065/ BLRJJ, BM1NH

Other recalls by Ultradent Products, Inc.

  • Z-3068-2024 Class II — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refil (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-3067-2024 Class II — Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/C (August 2, 2024)
  • 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-3217-2017 Class II — Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 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-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-3218-2017 Class II — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ste (August 4, 2017)