# FDA recall Z-0980-2025

> **Stryker Corporation** · Class II · device recall initiated 2023-06-28.

## Product

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology,  orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.  The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries.  These burs are sold as single use devices without their own IFU.

## Reason for recall

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).

## Distribution

Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.

## Key facts

- **Recall number:** Z-0980-2025
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-28
- **Report date:** 2025-01-29

- **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-0980-2025

## Citation

> AI Analytics. FDA recall Z-0980-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0980-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*