Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier
37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.
What this means for you
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 a labeling error (incorrect GTIN on carton label). No illnesses, injuries, or adverse health consequences have been reported. The hazard is a documentation and product identification issue rather than a defective device.
Plain-English summary
The FDA has issued a recall for 37 units of a Modular Stem cylindrical orthopedic implant (Product Code 880-601/11) manufactured by Waldemar Link GmbH & Co. KG. The implant is a press-fit cementless component measuring 80mm in length with an 11mm diameter.
The recall was initiated due to an incorrect Global Trade Item Number (GTIN) printed on the outer carton label. The GTIN that appears on the label belongs to a different product. This error was discovered during a scanning process.
The affected units are identified by the following lot numbers: 1943294, 1943296, 1943297, and 2049174. These implants were distributed across 14 U.S. states (Alabama, California, Colorado, Florida, Georgia, Indiana, Kansas, Missouri, New Jersey, Nevada, Ohio, Texas, Virginia, and Wisconsin) and internationally to Germany, Italy, Spain, and Switzerland.
No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- mis-labeling
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 (6)
- Product Code: 880-601/11
- UDI-DI: 04026575443925
- Lot Numbers: 1943294
- 1943296
- 1943297
- 2049174.
Distribution
Distributed nationwide across the United States.
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