Medical device recalls Moderate risk

Mako Surgical Corporation recalls MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defi…

Recall date
June 7, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2741-2017
FDA classification
Class II
Brand / firm
Mako Surgical Corporation
Sold / distributed
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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