Waldemar Link recalls SPII Model Lubinus Long Stem Prosthesis XL Neck cemented implants due to potential misinterpretation of carton labels during surgery. Affected units have specific 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 long stem prosthesis XL neck implants 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 could be misinterpreted during surgery, potentially leading to incorrect implant selection. This is based on two complaints about label interpretation, not actual injuries.
Orthopedic surgeons and medical professionals who use these implants during hip replacement surgeries. Patients who received these specific implant models are not at risk from the recall itself.
Check for product codes starting with 127-940/26 through 127-963/35 in the carton. These codes correspond to specific models of the SPII Lubinus Long Stem Prosthesis XL Neck cemented implants.
Check the carton for size and type columns to ensure correct interpretation before surgery.
Waldemar Link has identified potential misinterpretation of carton labels for size and type columns during surgery, based on two complaints.
No, the recall does not require stopping use. Surgeons should review carton labels carefully to avoid misinterpretation.
Product codes starting with 127-940/26 through 127-963/35 for the SPII Lubinus Long Stem Prosthesis XL Neck cemented implants.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1299-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1299-2024 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.
