# FDA recall Z-3067-2024

> **Ultradent Products, Inc.** · Class II · device recall initiated 2024-08-02.

## Product

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

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

## Key facts

- **Recall number:** Z-3067-2024
- **Recalling firm:** Ultradent Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-02
- **Report date:** 2024-09-18

- **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-3067-2024

## Citation

> AI Analytics. FDA recall Z-3067-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-3067-2024. Source: US FDA. Licensed CC0.

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