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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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 →Related recalls
Same manufacturer · Mako Surgical Corporation
See all →- ModerateStryker USB Converter in Mako Robotic Surgery System May Fail
FDA (Devices) · 2022-09-21
- HighMako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
FDA (Devices) · 2020-11-25
- HighMako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
FDA (Devices) · 2020-08-12
- ModerateMako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
- ModerateMako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateMako Surgical Recalls Robotic Arm Interactive Orthopedic System for Manual Revision
FDA (Devices) · 2016-04-27
- HighMako Surgical Recalls RIO System Software Due to Tactile Feedback Loss
FDA (Devices) · 2012-11-28
- SevereMako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
FDA (Devices) · 2015-02-25
- ModerateMako Surgical Recalls MAKO RIO THA Application User Guides
FDA (Devices) · 2017-03-15
- HighMako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues
FDA (Devices) · 2018-08-22
- HighMako RIO Robotic System Components Recalled for Damaged Locking Pins
FDA (Devices) · 2015-11-11