Lower riskMedical device recall · FDA · Published February 14, 2025
Waldemar Link Modular Stem Recall: Incorrect Label Causes Confusion
Waldemar Link recalls specific modular stem implants due to incorrect outer carton label GTIN causing confusion with other products. Affected units have Product Code 880-601/11 and Lot Numbers 1943294-1943297, 2049174.
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.
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Contact the company
📍Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
“Waldemar Link Modular Stem Recall: Incorrect Label Causes Confusion.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52856-waldemar-link-modular-stem-recall-incorrect-label-causes-confusion. Based on FDA recall #Z-1372-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1372-2025%22&limit=1).
The FDA announced on Feb. 14, 2025, that Waldemar Link GmbH & Co. KG is recalling Modular Stem cylindrical, Tilastan¿, press-fit cementless hip stems due to an incorrect GTIN on the outer carton label. The error involves a GTIN for a different product.
How to tell if you have it
Brand: Waldemar Link
Product: Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm
Product Code: 880-601/11
UDI-DI: 04026575443925
Lot Numbers: 1943294, 1943296, 1943297, 2049174
Quantity: 37 units
The hazard
The recall addresses a problem 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.
Context
GovInfoNow's records show Waldemar Link GmbH & Co. KG has 21 other recalls on record since 2018-12-04. Other recent recalls of similar products include the Endo-Model Tibial Plateau Recall (2026-07-06), the Embrace Drill Tower Wedged (25mm) Recall (2026-02-11), and the Endo-Model Plateau Recall (2026-01-12). Other recent recalls of similar products include the BIOSURE HA Screw Recall (2025-11-24), the GM Helix Dental Implant Recall (2026-07-13), and the TRACH TUBE KIT Recall (2026-07-10).
How to tell if you have this one
Check for Product Code 880-601/11 and Lot Numbers 1943294, 1943296, 1943297, or 2049174 on the carton. The product is a modular stem implant used in joint replacements.
Brand
Waldemar Link
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
Recall number
Product, codes & lots
Quantity
Z-1372-2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11; Product Code: 880-601/11; UDI-DI: 04026575443925; Lot Numbers: 1943294, 1943296, 1943297, 2049174.
37 units
Z-1373-2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12; Product Code: 880-601/12; UDI-DI: 04026575443932; Lot Numbers: 1943274, 1943276, 2049172, 2049173, 2049175.
52 units
Z-1374-2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13; Product Code: 880-601/13; UDI-DI: 04026575443949; Lot Numbers: 1943277, 1943280.
20 units
Based on the official FDA remedy
What to do — step by step
Check Carton Label
Verify the Product Code and Lot Numbers on the outer carton to determine if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, Nevada, New Jersey, Ohio, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1372-2025 (February 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1372-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.