Mako Surgical Recalls Robotic Knee System Due to Software Display Error
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could affect surgical guidance, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application (PKA) software for the Robotic Arm Interactive Orthopedic System (RIO). The recall is due to a software discrepancy where the system may not display all essential engineering (EE) constants when the screen is filled.
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 affected software is distributed worldwide, including nationwide in the United States and in various international locations.
The recall covers 349 units in the US and 78 units outside the US. All lot codes are affected. The source text does not report any specific injuries or illnesses associated with this software discrepancy.
The recalled product
- Product
- Makoplasty Partial Knee Application (PKA) 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…
- Manufacturer
- Mako Surgical Corporation
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 defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereMako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
FDA (Devices) · 2015-02-25
- ModerateMako Surgical Recalls RIO Standard System Components for Connection Errors
FDA (Devices) · 2018-09-26
- HighMako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues
FDA (Devices) · 2018-08-22
- HighMako Surgical Recalls RIO System Software Due to Tactile Feedback Loss
FDA (Devices) · 2012-11-28
- HighMako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery
FDA (Devices) · 2024-06-05
- ModerateMako Surgical Recalls Robotic Arm Interactive Orthopedic System for Manual Revision
FDA (Devices) · 2016-04-27