Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
This recall has been terminated (originally issued August 3, 2017).
- Company
- Ivoclar Vivadent, Inc.
- Recall Initiated
- August 3, 2017
- Terminated
- August 28, 2018
- Recall Number
- Z-0666-2018
- Quantity
- 3,255 units
- Firm Location
- Amherst, NY
- Official Source
- View on FDA website ↗
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.
Distribution
US and Canada
Lot / Code Info
Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch: V51367, Exp. date: 22.01.2021; Batch: W00520, Exp. date: 29.01.2021; Batch: W01514, Exp. date: 04.02.2021; Batch: W07036, Exp. date: 05.03.2021; Batch: W13323, Exp. date: 07.04.2021
Root Cause
Nonconforming Material/Component
Action Taken
The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.