Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 an

U.S. FDA — Device Enforcement · United States · 2024-08-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3067-2024
Date of alert: 2024-08-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ultradent Products, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00883205033680

Reported risk: Due to a manufacturing issue, red particulates present in the expressed composite.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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