FDA recall Z-0982-2025

Stryker Corporation · Class II · device

Product

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

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 5820-107-430 but package contains a 5820-107-530 device or vice versa).

Distribution

Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

Key facts

Status: Ongoing
Initiation date: 2023-06-28
Report date: 2025-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2025