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.
What You Should Do
Remedy
On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
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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 ceme
- Brand
- Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
- UPC
- Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Units Affected
321 units