Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Reported: February 28, 2018 Initiated: August 3, 2017 #Z-0666-2018
Product Description
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
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
- 3,255 units
- Distribution
- US and Canada
- Location
- Amherst, NY
Frequently Asked Questions
What product was recalled? ▼
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502. Recalled by Ivoclar Vivadent, Inc.. Units affected: 3,255 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-0666-2018.
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