# FDA recall Z-1368-2022

> **Ultradent Products, Inc.** · Class II · device recall initiated 2022-06-01.

## Product

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

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.

## Key facts

- **Recall number:** Z-1368-2022
- **Recalling firm:** Ultradent Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2022

## Citation

> AI Analytics. FDA recall Z-1368-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1368-2022. Source: US FDA. Licensed CC0.

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