Device product
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Z-1100-2022
Product summary
- Event
- Event 90031
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-1100-2022
Official wording
Reason: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Code information: LOT No.: 611612 (UDI): 07540172000178
Distribution pattern: Distributed in SC.
Derived failure modes
-
Unknown
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK