Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
Ivoclar Vivadent is recalling two units of Heliomolar Refill 20x0.25g 110T because the material was reported to be too soft and sticky, affecting handling.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic or handling defect (consistency) rather than a safety hazard like contamination or structural failure.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling two units of Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559. The affected units are identified by Batch W12503 and have an expiration date of 01.04.2021. The product was distributed in the US and Canada.
The recall was initiated after complaints were filed claiming the material consistency was too soft and too sticky compared to its usual consistency. This deviation caused unexpected handling for the user during packing and contouring.
The U.S. Food and Drug Administration has classified this recall as Class III. Consumers and healthcare professionals with this specific product should stop using it and contact the recalling firm for instructions.
The recalled product
- Product
- Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
- Manufacturer
- Ivoclar Vivadent, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch: W12503
- Exp. date: 01.04.2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Ivoclar Vivadent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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