Waldemar Link recalls Endo Model Modular Femur and Tibia prostheses with blind screws that may not loosen during surgery, causing prolonged procedures. Affected models include X-Small, Small, Medium, and Large sizes.
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Waldemar Link is recalling certain orthopedic prostheses due to a risk that blind screws in the tibial component cannot be loosened during surgery. This could lead to longer surgical times if an intraoperative change in procedure is needed.
The blind screws in the tibial component may not loosen properly during surgery. This could require the surgical team to change procedures mid-operation, leading to longer surgery times and potential complications.
Orthopedic surgeons and medical professionals who use these specific prosthetic models during surgery are most at risk. Patients receiving these implants may also be affected if the device is part of their surgical procedure.
Check for model numbers X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, or Large, Right 15-3818/11. Also look for UDI-DI codes like 04026575034727 or serial numbers such as 200818/1709.
Identify the model number and UDI-DI code on the prosthesis to confirm if it is affected.
Reach out to Waldemar Link directly for further guidance on the recall and potential remedies.
The recall is due to a risk that blind screws in the tibial component may not loosen during surgery, potentially requiring a change in procedure and prolonging surgery.
Affected models include X-Small, Right 15-3815/11; Small, Right 15-3816/11; Small, Left 15-3816/12; Medium, Right 15-3817/11; Medium, Left 15-3817/12; and Large, Right 15-3818/11.
Check for the specific model numbers and UDI-DI codes listed in the recall notice, such as 04026575034727 for X-Small, Right.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2022 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1378-2022 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.
