Stryker Leibinger DirectInject: Injection Failure Risk
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.
Lower-risk recall
Inability for the user to inject the paste from the syringe into the target location.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62864-stryker-leibinger-directinject-injection-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62864-stryker-leibinger-directinject-injection-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1436-2021
Cite this page
“Stryker Leibinger DirectInject: Injection Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62864-stryker-leibinger-directinject-injection-failure-risk. Based on FDA recall #Z-1436-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Users of DirectInject cement paste systems for medical procedures. Medical professionals who use the product for bone fixation are most at risk.
How to tell if you have this one
Check for lot numbers DI20311 or DI20307 and product code 07613327123265 on the DirectInject system.
- Brand
Stryker Leib:ing- Category
Medical device
What to do — step by step
Check Product Details
Look for lot numbers DI20311 or DI20307 and product code 07613327123265 on the DirectInject system.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1436-2021 (April 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1436-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.