Waldemar Link Knee Fusion Nail Recall: Wrong Screw Insertion Risk
Waldemar Link recalls specific knee fusion nails due to a preassembled locking screw inserted from the wrong side, potentially causing improper joint alignment during surgery.
Lower-risk recall
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Contact the company
What happened, in plain English
Waldemar Link is recalling certain knee fusion nails because they were shipped with a locking screw inserted from the wrong side. This could lead to improper joint alignment during surgery, which may affect the outcome of the procedure. Read more at govinfonow.com/recall/50699-waldemar-link-knee-fusion-nail-recall-wrong-screw-insertion-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/50699-waldemar-link-knee-fusion-nail-recall-wrong-screw-insertion-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0890-2026
Cite this page
“Waldemar Link Knee Fusion Nail Recall: Wrong Screw Insertion Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50699-waldemar-link-knee-fusion-nail-recall-wrong-screw-insertion-risk. Based on FDA recall #Z-0890-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0890-2026%22&limit=1).
Why it’s dangerous
The locking screw was inserted from the wrong side into the male taper of the femoral component. This could cause improper alignment of the knee joint during surgery, potentially leading to complications in the fusion process.
Who’s affected
Patients who received the recalled knee fusion nails during surgery are affected. Surgeons and medical teams using these specific implants are at the highest risk.
How to tell if you have this one
Check for the item number 15-0028/08, lot number 2535004, or UDI-DI 04026575175222 on the implant. The product is a knee fusion nail used in limb salvage replacement devices.
- Brand
Waldemar Link- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Waldemar Link directly for guidance on the recalled implant and next steps.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US distribution to states of: AL, GA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Georgia, Texas.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall addresses a potential issue with improper joint alignment during surgery, but the risk is considered low as it relates to surgical technique rather than immediate harm.
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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-0890-2026 (November 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0890-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.