Device product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Z-1374-2025
Product summary
- Event
- Event 96386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1374-2025
Official wording
Reason: 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.
Code information: Product Code: 880-601/13; UDI-DI: 04026575443949; Lot Numbers: 1943277, 1943280.
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
label because of an incorrect