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.
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.
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.
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.
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.
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.
Reach out to Waldemar Link directly for guidance on the recalled implant and next steps.
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.
Check for the item number 15-0028/08, lot number 2535004, or UDI-DI 04026575175222 on the implant.
Contact Waldemar Link directly for guidance on the recalled implant and next steps.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-0890-2026 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-0890-2026 from Waldemar Link. 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.
