Z-0668-2018 Class III Terminated
FDA device recall Z-0668-2018 was initiated by Ivoclar Vivadent, Inc. on August 3, 2017 and is designated Class III. 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. The recall status is terminated (terminated August 28, 2018). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- August 3, 2017
- Termination Date
- August 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
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 Pattern
US and Canada
Code Information
Batch: W12503, Exp. date: 01.04.2021