Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Reported: February 28, 2018 Initiated: August 3, 2017 #Z-0665-2018
Product Description
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Reason for Recall
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.
Details
- Recalling Firm
- Ivoclar Vivadent, Inc.
- Units Affected
- 2,153 units
- Distribution
- US and Canada
- Location
- Amherst, NY
Frequently Asked Questions
What product was recalled? ▼
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501. Recalled by Ivoclar Vivadent, Inc.. Units affected: 2,153 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Low. Recall number: Z-0665-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11