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

FDA Recall #Z-0981-2025 — Class II — June 28, 2023

Recall #Z-0981-2025 Date: June 28, 2023 Classification: Class II Status: Ongoing

Product Description

stryker 3.0MM Neuro Match Head, REF 5820-107-430, 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).

Recalling Firm

Stryker Corporation — Portage, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

464 units

Distribution

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

Code Information

GTIN 04546540467775, Lot Number 22174017

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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