Stryker Leibinger GmbH & Co. KG recalls DirectInject consists of a sterile dual paste system which i
Recalled 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.
Hazard / Issue
Inability for the user to inject the paste from the syringe into the target location.
Issued by
FDA
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