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

Recall Z-0213-2016 — Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featurin

U.S. FDA — Device Enforcement · Liechtenstein · 2015-10-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0213-2016
Date of alert: 2015-10-07
Country / jurisdiction: Liechtenstein
Risk level: Class II
Risk type: recall
Brand: Ivoclar A. G.
Product category: device
Product type: Devices

Reported risk: A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

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

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.

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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