Waldemar Link recalls a specific knee prosthesis segment due to potential failure to meet specifications. Affected units include the right femoral segment size 3 with item number 15-2973/05.
The firm discovered through customer complaints that device segments may not meet specifications.
Waldemar Link is recalling a specific right knee prosthesis segment (size 3) because it may not meet required specifications. This could affect the safety and proper function of the implant.
The prosthesis segment may not meet specifications, which could lead to improper function or safety issues during use. This is a manufacturing issue that affects the fit and performance of the implant.
Patients who received the specific right femoral segment size 3 (item number 15-2973/05) from Waldemar Link are affected. Those with this implant are most at risk.
Check for the product name 'LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right' with item number 15-2973/05. The UDI-DI code 04026575340699 is also associated with this specific model.
Verify the item number 15-2973/05 and UDI-DI code 04026575340699 on your prosthesis segment.
This recall specifically affects the right femoral segment size 3 with item number 15-2973/05. Check your product details to see if you are affected.
The recall does not specify a remedy, so you should check with Waldemar Link directly for guidance.
Look for the item number 15-2973/05 and UDI-DI code 04026575340699 on your prosthesis segment.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2046-2023 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-2046-2023 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.