FDA-Device2021-04-28Class II
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.
Hazard
Inability for the user to inject the paste from the syringe into the target location.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Affected count
321 units
Manufactured in
Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1436-2021Don't want to check this manually?
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