Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling
Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with incorrect GTIN labeling. The hazard is administrative—a barcode error on the carton that could theoretically lead to product misidentification. No illnesses or injuries have been reported. Classified as moderate severity per FDA guidelines for labeling errors without reported incidents.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 20 units of Modular Stem cylindrical, Tilastan®, press-fit cementless orthopedic implants (Product Code 880-601/13, Lot Numbers 1943277 and 1943280) due to labeling defects on the outer carton. The carton label displays an incorrect GTIN (barcode) that belongs to a different product, rather than the correct identifier for this implant.
The error was discovered during carton label scanning. The affected units were distributed nationwide in 14 U.S. states—Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia, and Wisconsin—and internationally in Germany, Italy, Spain, and Switzerland.
The correct product can be verified using the printed Product Code (880-601/13), the UDI-DI (04026575443949), or the Lot Numbers (1943277 or 1943280).
The recalled product
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Code: 880-601/13
- UDI-DI: 04026575443949
- Lot Numbers: 1943277
- 1943280.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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