Mako Surgical Recalls RIO System Software Due to Tactile Feedback Loss
Mako Surgical Corporation is recalling 137 RIO System devices to replace software version 2.4 with 2.5, addressing a functional issue involving the loss of tactile feedback.
What this means for you
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 is classified as FDA Class II, and the hazard involves a loss of tactile feedback in a surgical device, which presents a risk of harm where injury has not yet been reported.
Plain-English summary
Mako Surgical Corporation is recalling 137 units of the RIO System, Model # MAKO TGS 2.0 (Part No. 204000), to address a software functional issue. The recall involves replacing software version 2.4 with version 2.5. The RIO system is a medical device intended to assist surgeons in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically unicondylar knee replacement, patellofemoral knee replacement, and total hip arthroplasty.
The recall is being implemented because a loss of tactile feedback constraining the cutting burr has been reported. This functional issue affects the system's ability to provide the intended tactile constraints during surgical procedures.
The affected devices were distributed worldwide, including in the United States and internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea. Specific serial numbers for the affected robotic, guidance, and camera units are listed in the official recall documentation. Healthcare facilities and users should contact Mako Surgical Corporation for instructions on updating the software to version 2.5.
The recalled product
- Product
- The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in
- Manufacturer
- Mako Surgical Corporation
- Affected units
- 137
Distribution
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 →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25