FDAClass IIFebruary 28, 2018

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted recall

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to…

Why was ROSA Brain 3.0 Stereotaxic instrument Computer-assisted recalled?

Robot arm being sent to the wrong position

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?

BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025.

Product
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to…
Recalling firm
Zimmer Biomet, Inc.
Quantity
16
Distribution
Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Recall date
February 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls