Waldemar Link recalls Endo Model M Tibial Components Modular Knee Prosthesis Systems with product codes 15-2814/01 to 15-8521/35. Blind screws may not loosen during surgery, prolonging procedures.
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 Endo Model M Tibial Components Modular Knee Prosthesis Systems because blind screws cannot be loosened during surgery. This could lead to longer surgeries and potential complications if the cementing technique needs adjustment.
The blind screws in the modular tibial component cannot be loosened during surgery. This may require the surgeon to change procedures, such as adjusting cementing techniques, which can prolong surgery time and increase risks.
Orthopedic surgeons and medical facilities using the Endo Model M Tibial Components Modular Knee Prosthesis Systems with product codes 15-2814/01 through 15-8521/35. Surgeons performing knee replacements are most at risk.
Check for product codes 15-2814/01 through 15-8521/35 on the packaging or documentation. These components were manufactured starting June 1, 2022.
Identify if your Endo Model M Tibial Components have product codes 15-2814/01 through 15-8521/35.
Reach out to Waldemar Link for guidance on next steps if you have the recalled product codes.
The blind screws in the modular tibial component cannot be loosened during surgery, which may require changing procedures like cementing techniques and prolong surgery time.
Product codes 15-2814/01 through 15-8521/35, manufactured starting June 1, 2022.
No, but surgeons should be aware of the risk and contact Waldemar Link for guidance if they have the recalled product codes.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2410-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-2410-2024 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.
