# FDA recall Z-2541-2025

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2025-07-31.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2541-2025
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-31
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norderstedt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2025

## Citation

> AI Analytics. FDA recall Z-2541-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2541-2025. Source: US FDA. Licensed CC0.

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