FDA-Device2025-01-29Class II

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

Stryker Corporation
Hazard

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).

Sold states
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Affected count
464 units
Manufactured in
1941 Stryker Way, Portage, MI, United States
Products
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0981-2025

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