Waldemar Link recalls specific hip prosthesis stems due to potential misinterpretation of carton labels during surgery. Affected models include SPII Lubinus Hip Prosthesis Stem XL Neck cemented with certain 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 specific hip prosthesis stems 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 recall addresses potential confusion between the 'Size' and 'Type' columns on the product carton. Misreading these labels could lead to incorrect surgical decisions, but the hazard is not a physical risk to the patient during normal use.
Orthopedic surgeons and medical professionals who use these hip prosthesis stems during surgery. Patients receiving these implants are not directly affected by the recall.
Check for the product codes listed in the recall: 127-740/17 through 127-773/26 with corresponding UDI/DI numbers. These stems are cemented hip prosthesis implants used in surgery.
Check the 'Size' and 'Type' columns on the product carton to ensure correct interpretation before surgery.
No, the recall does not require stopping use. Surgeons should review carton labels carefully to avoid misinterpretation.
Affected product codes include 127-740/17 through 127-773/26 with specific UDI/DI numbers listed in the recall.
The recall addresses potential misinterpretation during surgery by medical staff, not direct patient risk. Patients are not affected by this recall.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1297-2024 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1297-2024 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.
