FDAFDA · Food and drugs·Recall number Z-3067-2024
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
Published September 18, 2024 · Recall initiated: August 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing issue, red particulates present in the expressed composite.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultradent Products, Inc.
- Distributor
- 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
- Lot
- Lot Code: Model No 4817; UDI-DI 00883205033680; Lot Number C1464; Expiration Date 30-Jun-2026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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