# FDA recall Z-2411-2024

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2024-05-22.

## Product

Endo Model  SL Tibial Components																  16-2817/02	Tibial Component, Small, W: 60mm  16-2817/05	Tibial Component, Medium, W: 65mm  16-2817/07	Tibial Component, Large, W: 75mm  16-2817/32	Tibial Component Modular, Small, W: 60mm  16-2817/35	Tibial Component Modular, Medium, W: 65mm  16-2817/37	Tibial Component Modular, Large, W: 75mm

## Reason for recall

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

## Distribution

Nationwide Foreign:  Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam

## Key facts

- **Recall number:** Z-2411-2024
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-07-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2411-2024

## Citation

> AI Analytics. FDA recall Z-2411-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2411-2024. Source: US FDA. Licensed CC0.

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