FDAClass IINovember 29, 2017

Rosa Brain 3.0.0 recall

ROSA BRAIN 3.0.0

Why was Rosa Brain 3.0.0 recalled?

Non-conforming product label.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Serial No. BR16017 and BR16018

Product
ROSA BRAIN 3.0.0
Recalling firm
Zimmer Biomet, Inc.
Quantity
2 devices
Distribution
OH and PA.
Recall date
November 29, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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