PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 29, 2025 Initiated: June 28, 2023 #Z-0982-2025

Product Description

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).

Details

Recalling Firm
Stryker Corporation
Units Affected
1489 units
Distribution
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery. Recalled by Stryker Corporation. Units affected: 1489 units.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-0982-2025.