Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DirectInject consists of a sterile dual paste system which is Recalled by Stryker Leibinger GmbH & Co. KG Due to Inability for the user to inject the paste...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Leibinger GmbH & Co. KG directly.
Affected 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.
Quantity: 321 units
Why Was This Recalled?
Inability for the user to inject the paste from the syringe into the target location.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Leibinger GmbH & Co. KG
Stryker Leibinger GmbH & Co. KG has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report