FDAClass IINovember 22, 2017

ROSA Surgical Device 2.5.8 ROSA Surgical Device is a recall

ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for…

Why was ROSA Surgical Device 2.5.8 ROSA Surgical Device is a recalled?

Potential failure of the optical distance sensor due to cable disconnection.

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. RO10011 and RO10014

Product
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for…
Recalling firm
Zimmer Biomet, Inc.
Quantity
14 units
Distribution
Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Recall date
November 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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