# FDA recall Z-0431-2021

> **Stryker Instruments Div. of Stryker Corporation** · Class II · device recall initiated 2020-10-16.

## Product

Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients.    Catalog Number: 5100-060-001

## Reason for recall

Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

## Distribution

Nationwide  Foreign:  Australia  Brazil  Canada  Chile  Colombia  Hong Kong  Italy  Mexico  Netherlands  Netherlands  New Zealand  South Africa  South Korea  Spain  Sweden  Switzerland  United Kingdom

## Key facts

- **Recall number:** Z-0431-2021
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-16
- **Report date:** 2020-11-18
- **Termination date:** 2022-06-22

- **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-0431-2021

## Citation

> AI Analytics. FDA recall Z-0431-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0431-2021. Source: US FDA. Licensed CC0.

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