FDA-Device2025-09-17Class II
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Sold states
Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Affected count
8 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2025Don't want to check this manually?
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