Waldemar Link recalls specific modular stem implants due to a mislabeled carton causing confusion with another product. No safety risk but requires checking product codes.
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Waldemar Link is recalling a specific type of modular stem implant because the carton label had an incorrect product code. This is a labeling error that could cause confusion with another product but does not pose a safety risk.
The carton label had an incorrect GTIN (Global Trade Item Number) that matches a different product. This labeling error could lead to confusion when trying to identify the correct implant, but it does not cause physical harm or safety issues.
Orthopedic surgeons and patients who purchased the specific modular stem implant (Product Code 880-601/13) from the listed lot numbers. Patients using this implant for joint replacements are most at risk of confusion with another product.
Check for Product Code 880-601/13 on the implant and Lot Numbers 1943277 or 1943280. The UDI-DI number 04026575443949 is also associated with this specific recall.
Look for Product Code 880-601/13 on the implant to confirm it is part of this recall.
Confirm the implant has Lot Numbers 1943277 or 1943280 to identify affected units.
No, this recall is for labeling confusion only. There is no safety risk involved.
Check the Product Code and Lot Numbers to see if it is part of this recall. No action is needed if it is not affected.
Look for Product Code 880-601/13 and Lot Numbers 1943277 or 1943280 on the implant.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1374-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1374-2025 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.
