Ultradent Products, Inc.: Device Recall
Recall #Z-3067-2024 · 08/02/2024
Recall Details
- Recall Number
- Z-3067-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ultradent Products, Inc.
- Status
- Ongoing
- Date Initiated
- 08/02/2024
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560
Reason for Recall
Due to a manufacturing issue, red particulates present in the expressed composite.
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
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
Other Recalls by Ultradent Products, Inc.
- Class II: Risk 08/02/2024
- Class II: Risk 08/02/2024