Waldemar Link recalls Endo Model SL Tibial Components with blind screws that cannot be loosened during surgery, potentially causing prolonged procedures. Affected units manufactured since June 1, 2022.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Waldemar Link is recalling specific tibial components used in joint surgery because their blind screws cannot be loosened during surgery. This could lead to longer surgeries and complications if the procedure needs adjustment. Patients using these components should contact the manufacturer for details.
The blind screws in these tibial components cannot be loosened during surgery. This means if the surgeon needs to change the procedure, like adjusting cementing technique, they cannot fix the issue without prolonging the surgery. Prolonged surgery increases risks like infection and blood clots.
Orthopedic surgeons and medical facilities that use the Endo Model SL Tibial Components. Those most at risk are patients undergoing joint replacement surgery with these specific components.
Check for the model numbers 16-2817/02, 16-2817/05, 16-2817/07, 16-2817/32, 16-2817/35, or 16-2817/37 on the product. These components were manufactured starting June 1, 2022.
Look for the model numbers listed in the recall notice to confirm if your component is affected.
Reach out to Waldemar Link for specific instructions on how to handle the affected components.
The blind screws in these tibial components cannot be loosened during surgery, which may cause prolonged procedures if the surgeon needs to adjust the cementing technique.
No, these components pose a risk of prolonged surgery and potential complications if the surgeon needs to change the procedure.
Check for model numbers 16-2817/02, 16-2817/05, 16-2817/07, 16-2817/32, 16-2817/35, or 16-2817/37, which were manufactured starting June 1, 2022.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2411-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-2411-2024 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.
