FDAClass IIJuly 26, 2017

MAKO RIO Standard System recall

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during…

Why was MAKO RIO Standard System recalled?

An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

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?

Lot No. 05212015

Product
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during…
Recalling firm
Mako Surgical Corporation
Quantity
20
Distribution
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Recall date
July 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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