Reported Apr 27, 2016 · Terminated

Robotic Arm Interactive Orthopedic System (RIO)

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 · Plantation, FL · 33317-7424

Is this the product you have?

  • Robotic Arm Interactive Orthopedic System (RIO)
Lot codes and dates
  • Catalog # 203900 & 207092 All lots
Amount recalled
249

Where it was sold

  • Nationwide

Why it was recalled

Revision of the field manual

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Mako Surgical Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 24, 2019 · Data as of Sep 19, 6:01 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.