Device product
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Z-0668-2018
Product summary
- Event
- Event 79064
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0668-2018
Official wording
Reason: 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.
Code information: Batch: W12503, Exp. date: 01.04.2021
Distribution pattern: US and Canada
Derived failure modes
-
Unknown
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.