Stryker Leibinger recalls DirectInject cement paste system due to inability to inject paste into target location. Affected units have specific lot numbers and product codes.
Inability for the user to inject the paste from the syringe into the target location.
Stryker Leibinger is recalling DirectInject cement paste systems because users cannot properly inject the paste into the target location. This could prevent the product from working as intended.
The product is designed to form a cement paste that hardens into hydroxyapatite. However, the system fails to allow proper injection into the target location, which could prevent the intended medical use.
Users of DirectInject cement paste systems for medical procedures. Medical professionals who use the product for bone fixation are most at risk.
Check for lot numbers DI20311 or DI20307 and product code 07613327123265 on the DirectInject system.
Look for lot numbers DI20311 or DI20307 and product code 07613327123265 on the DirectInject system.
The product cannot be properly injected into the target location, which may prevent it from working as intended.
Check for lot numbers DI20311 or DI20307 and product code 07613327123265. If you have these, contact Stryker Leibinger for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Stryker Leib:ing to request your refund or repair — edit it as you like.
Subject: Recall Z-1436-2021 — Stryker Leib:ing Stryker Leib:ing Hello, I own a Stryker Leib:ing that is covered by recall Z-1436-2021 from Stryker Leib:ing. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
