Hip Prosthetic Stem Recalled for Incorrect Product Code Label
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
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 device with an incorrect GTIN on the carton label. No reported injuries or illnesses. This is a minor labeling error without reported harm.
Plain-English summary
The U.S. Food and Drug Administration is recalling the Modular Stem cylindrical (Tilastan, press-fit cementless) hip prosthetic, L=80 mm, DIA=12 mm, Product Code 880-601/12, manufactured by Waldemar Link GmbH & Co. KG. A total of 52 units were distributed.
The recall was initiated after a problem was discovered on the outer carton label during the scanning process. The label contains an incorrect GTIN (Global Trade Item Number) that belongs to a different product, creating the potential for product misidentification.
The affected units were distributed worldwide, including in the United States in Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia, and Wisconsin. The affected lot numbers are 1943274, 1943276, 2049172, 2049173, and 2049175.
No injuries or illnesses related to this issue have been reported. Healthcare providers and patients with questions about the affected lots should contact the manufacturer.
The recalled product
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- Affected units
- 52
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 (7)
- Product Code: 880-601/12
- UDI-DI: 04026575443932
- Lot Numbers: 1943274
- 1943276
- 2049172
- 2049173
- 2049175.
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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