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Recall Observatory FDA recall evidence

Device product

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

Z-1374-2025

February 14, 2025

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
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

    reason.labeling_packaging · v1.0.0

    label because of an incorrect