# FDA recall Z-1478-2022

> **Stryker Instruments** · Class II · device recall initiated 2022-06-24.

## Product

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

## Reason for recall

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Arizona, California,  Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas,  Virginia and the countries of Canada, Netherlands, and Thailand.

## Key facts

- **Recall number:** Z-1478-2022
- **Recalling firm:** Stryker Instruments
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-24
- **Report date:** 2022-08-03

- **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-1478-2022

## Citation

> AI Analytics. FDA recall Z-1478-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1478-2022. Source: US FDA. Licensed CC0.

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