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

Recall date

July 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2541-2025

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50