Waldemar Link recalls specific Modular Stem cylindrical implants due to a mislabeled GTIN on cartons causing confusion with other products. No safety risk exists; this is a labeling error.
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 outer carton label had an incorrect GTIN number. This mistake could cause confusion with other products but does not pose a safety risk to users.
The outer carton label had an incorrect GTIN (Global Trade Item Number) that matches a different product. This labeling error could lead to confusion during product identification but does not affect the implant's safety or function.
Orthopedic surgeons and medical professionals who purchased the specific Modular Stem cylindrical implants with Product Code 880-601/12. Patients using these implants are not at risk.
Check for Product Code 880-601/12 on the implant's carton. The Lot Numbers 1943274, 1943276, 2049172, 2049173, and 2049175 are also associated with this recall.
Verify the Product Code on the outer carton is 880-601/12 and the Lot Numbers match the listed numbers.
No, this recall is due to a labeling error that could cause confusion with other products but does not pose a safety risk to users.
Check the carton label for Product Code 880-601/12 and Lot Numbers 1943274, 1943276, 2049172, 2049173, or 2049175. No action is needed beyond verification.
The recall is for labeling confusion only; there is no risk of injury or harm from this 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-1373-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1373-2025 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.