Waldemar Link recalls specific Lubinus long stem prosthesis models due to potential misinterpretation of carton labels during surgery. Affected units have unique product codes.
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Waldemar Link is recalling certain Lubinus long stem prosthesis models because carton labels for size and type might be misinterpreted during surgery. This could lead to incorrect usage in medical procedures.
The carton labels for size and type columns could be misinterpreted during surgery, potentially leading to incorrect prosthesis selection. This might cause improper surgical outcomes if the wrong model is used.
Orthopedic surgeons and medical professionals who use these specific prosthesis models during hip replacement surgeries. Patients are not directly affected as the recall is for medical devices used by professionals.
Check for product codes starting with 127-910/26 through 127-933/35 on the carton. These codes correspond to specific Lubinus long stem prosthesis models.
Check the carton for product codes starting with 127-910/26 through 127-933/35 to confirm if the device is affected.
The recall is due to potential misinterpretation of carton labels for size and type during surgery, which could lead to incorrect prosthesis selection.
Look for product codes on the carton starting with 127-910/26 through 127-933/35.
No action is required for the products themselves; the recall is for label clarification to prevent misinterpretation during surgery.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1298-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1298-2024 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.
