# FDA recall Z-3245-2024

> **Waldemar Link GmbH & Co. KG (Corp. Hq.)** · Class II · device recall initiated 2024-09-11.

## Product

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

## Reason for recall

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

## Distribution

US Nationwide distribution in the states of FL, KS, MI, NJ, VA.

## Key facts

- **Recall number:** Z-3245-2024
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Corp. Hq.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-11
- **Report date:** 2024-10-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3245-2024

## Citation

> AI Analytics. FDA recall Z-3245-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-3245-2024. Source: US FDA. Licensed CC0.

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