Device product
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
Z-1436-2021
Product summary
- Event
- Event 87684
- Status
- Terminated
- Classification
- Class II
- Quantity
- 321 units
- Official record key
device-enforcement:Z-1436-2021
Official wording
Reason: Inability for the user to inject the paste from the syringe into the target location.
Code information: Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Derived failure modes
-
Unknown
Inability for the user to inject the paste from the syringe into the target location.