Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
Lot Codes / Batch Numbers
Lot: DI20311, DI20307 Product Code (UDI): 07613327123265
Products Sold
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany is recalling DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injectio due to Inability for the user to inject the paste from the syringe into the target location.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inability for the user to inject the paste from the syringe into the target location.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026