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

Recall Z-0665-2018 — Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0665-2018
Date of alert
2017-08-03
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ivoclar Vivadent, Inc.
Product category
device
Product type
Devices
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.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.

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