FDAClass IIJanuary 29, 2025

The 3.0MM Neuro Match Head Soft Touch bur recall

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…

Why was The 3.0MM Neuro Match Head Soft Touch bur recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 04546540362483, Lot Number 21341057

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…
Recalling firm
Stryker Corporation
Quantity
491 devices
Distribution
Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Recall date
January 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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