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

Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain — recall Z-0036-2017

U.S. FDA — Device Enforcement · United States · 2016-05-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0036-2017
Date of alert
2016-05-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ivoclar Vivadent, Inc.
Product category
device
Product type
Devices
Reported risk: The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.