Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Pa...

FDA Device Recall #Z-1368-2022 — Class II — June 1, 2022

Recall Summary

Recall Number Z-1368-2022
Classification Class II — Moderate risk
Date Initiated June 1, 2022
Status Completed
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ultradent Products, Inc.
Location South Jordan, UT
Product Type Devices
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.

Lot / 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 from Ultradent Products, Inc.

Recall # Classification Product Date
Z-3067-2024 Class II Brand Name: Transcend Product Name: Transcend ... Aug 2, 2024
Z-3068-2024 Class II Brand Name: Transcend Product Name: Transcend ... Aug 2, 2024
Z-3066-2024 Class II Brand Name: Vit-l-escence Product Name: Vit-l-... Aug 2, 2024
Z-0053-2021 Class II PermaFlo Flowable Composite REF-UP 948 Shade: A... Aug 31, 2020
Z-0690-2019 Class II Enamelast Cool Mint/OT Varnish 5% NaF Mint L... Jul 12, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.