# FDA recall Z-0890-2026

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2025-11-10.

## Product

Endo Model Knee Fusion Nail SK, Knee Fusion  Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

## Reason for recall

The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

## Distribution

US distribution to states of: AL, GA, and TX.

## Key facts

- **Recall number:** Z-0890-2026
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-10
- **Report date:** 2025-12-17

- **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-0890-2026

## Citation

> AI Analytics. FDA recall Z-0890-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0890-2026. Source: US FDA. Licensed CC0.

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