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

Recall Z-0028-2020 — Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities

U.S. FDA — Device Enforcement · Germany · 2019-07-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0028-2020
Date of alert
2019-07-09
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Voco GmbH
Product category
device
Product type
Devices
Reported risk: The metal cannula are potentially too loose and may become loose when applying the filing material.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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