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

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog… — recall Z-0666-2018

U.S. FDA — Device Enforcement · United States · 2017-08-03 · Class III

As described by U.S. FDA — Device Enforcement: Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0666-2018
Date of alert
2017-08-03
Country / jurisdiction
United States
Risk level
Class III
Notice type
recall
Brand
Ivoclar Vivadent, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US and Canada
Reported risk: Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
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.