The Recall Desk
ModerateFDA (Devices)·Z-3131-2017·Announced 2017-09-20

Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software

Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software display error, which fits the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.

Plain-English summary

Mako Surgical Corporation is recalling the Total Hip Application (THA) software for the Robotic Arm Interactive Orthopedic System (RIO). The recall involves 291 units in the United States and 66 units outside the US. The RIO system is intended to assist surgeons by providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The recall was initiated due to a software discrepancy where the screen may fail to display all essential engineering (EE) constants when the screen is filled. This issue affects all lot codes of the product.

The affected units were distributed nationwide in the US and in various countries including Australia, China, Greece, the United Kingdom, Germany, India, Japan, and others. Users of the RIO system should contact Mako Surgical Corporation for further instructions regarding the software update or replacement.

The recalled product

Product
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Manufacturer
Mako Surgical Corporation
Category
Medical Device — Surgical Robotics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Mako Surgical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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