Device product
impression coping, repositionable, short, screw-retained, PF 4.0
Z-1322-2024
Product summary
- Event
- Event 94040
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1322-2024
Official wording
Reason: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Code information: Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
Distribution pattern: US Nationwide distribution in the states of OH and KY.
Derived failure modes
-
Unknown
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.