# FDA recall Z-2597-2023

> **Stryker Corporation** · Class II · device recall initiated 2023-08-07.

## Product

Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000

## Reason for recall

Potential for the Break-Away Femoral Nozzle  the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

## Distribution

Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK

## Key facts

- **Recall number:** Z-2597-2023
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-07
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2597-2023

## Citation

> AI Analytics. FDA recall Z-2597-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2597-2023. Source: US FDA. Licensed CC0.

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