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LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed...

FDA Recall #Z-2541-2025 — Class II — July 31, 2025

Recall #Z-2541-2025 Date: July 31, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

8 units

Distribution

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

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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