Reported Jul 26, 2017 · Terminated

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

Mako Surgical Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Davie, FL · 33317-7424

Is this the product you have?

  • MAKO RIO Standard System
  • internal cPCI Card CageP/N201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures
Lot codes and dates
  • Lot No. 05212015
Amount recalled
20

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 16, 2020 · Data as of Sep 19, 6:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.