Waldemar Link recalls Endo Model Modular Rotational Tibia prostheses (Small, Medium, Large) due to risk of blind screws not loosening during surgery, potentially prolonging procedures. Affected units have specific model numbers and serial dates.
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 Endo Model Modular Rotational Tibia prostheses for small, medium, and large sizes. The recall is because blind screws in these implants might not loosen during surgery, which could lead to longer procedures and changes in how the surgery is performed.
The blind screws in the modular tibial component may not loosen properly during surgery. This can cause the surgical team to change procedures mid-operation, potentially prolonging the surgery and increasing risks for the patient.
Orthopedic surgeons and medical professionals who use these implants during surgery are most at risk. Patients who have received these specific prostheses are also affected.
Check for model numbers: #15-2814/02 (Small), #15-2814/03 (Medium), #15-2814/04 (Large). Look for serial/lot numbers listed in the recall notice, which include specific date ranges like 210420/0762 through 211115/2111.
Identify if your implant is one of the recalled Endo Model Modular Rotational Tibia prostheses with model numbers #15-2814/02, #15-2814/03, or #15-2814/04.
Reach out to Waldemar Link directly to confirm if your specific implant is affected and to get guidance on next steps.
The recall is due to a risk that blind screws in the modular tibial component cannot be loosened intraoperatively, which may lead to prolonged surgery and changes in procedure.
The affected models are Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04).
Check the serial/lot numbers listed in the recall notice, which include specific date ranges like 210420/0762 through 211115/2111.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1377-2022 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1377-2022 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.
