Waldemar Link recalls SPII Model Lubinus hip prosthesis stems due to potential misinterpretation of carton labels during surgery. Affected units have specific product codes; no immediate action required but clarification needed.
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 hip prosthesis stems (SPII Model Lubinus) because carton labels may be misinterpreted during surgery. This could lead to incorrect surgical decisions if the size and type columns are not read correctly.
The carton labels for size and type columns may be misinterpreted during surgery, which could lead to incorrect surgical decisions. This is based on two complaints about label interpretation, not actual injuries.
Patients who have received the recalled hip prosthesis stems during surgery are likely affected. Surgeons and medical staff using these stems are at the highest risk due to potential misinterpretation during procedures.
Check for product codes listed in the recall: 127-610/17 (04026575387168) through 127-739/35 (04026575225491). These are specific model numbers for the hip prosthesis stems.
Look for the product codes listed in the recall to confirm if your hip prosthesis stem is affected.
No immediate danger is reported; the recall is due to potential label misinterpretation during surgery, not actual injuries or hazards.
No, the recall does not require stopping use; it only asks for label clarification to avoid misinterpretation during surgery.
Check if your product code matches the list provided in the recall: 127-610/17 (04026575387168) through 127-739/35 (04026575225491).
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1296-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1296-2024 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.
