FDAClass IISeptember 18, 2024

Medtronic ENT Ultra Round Steel Cutting Bur recall

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

Why was Medtronic ENT Ultra Round Steel Cutting Bur recalled?

Product was distributed past expiration date.

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?

UDI/DI 0076300004142, Lot Number 0219937928

Product
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Recalling firm
Medtronic Xomed, Inc.
Quantity
1 unit
Distribution
International distribution to the country of Canada.
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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