FDAHealthJuly 31, 2025

Waldemar Link GmbH & Co. KG (Mfg Site) — LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50

⚠️ Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 31, 2025

Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.

What's affected?

Product: LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Brand: Waldemar Link GmbH & Co. KG (Mfg Site)
Lot code: REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.

Additional details

REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 8 units.

View original FDA notice →

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