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.
Stryker Leibinger GmbH & Co. KG
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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