Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a surgical instrument malfunction that could cause significant injury during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application (PKA) RIO (TGS 2.0). This software application is used with the Robotic Arm Interactive Orthopedic System (RIO) for surgical knee procedures. The recall covers all lots with part numbers 201000, 203999, 207300, and 209930.
The recall was initiated because, when using the MAKOplasty partial knee Arthroplasty application, the surgical burr continues to spin outside of the stereotactic boundary even after the control switches (foot pedal and trigger) cease to be activated. This malfunction presents a risk of unintended tissue damage during surgery.
The affected units were distributed nationwide, including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and Hawaii. Healthcare facilities and users should stop using the affected software and contact Mako Surgical Corporation for instructions on how to proceed.
The recalled product
- Product
- Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
- Manufacturer
- Mako Surgical Corporation
- Affected units
- 228
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 (5)
- All lots
- Part Numbers: 201000
- 203999
- 207300
- and 209930.
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 · unintended motion
See all →- HighInfinia nuclear medicine systems may show unintended radial detector motion
FDA (Devices) · 2025-07-16
- HighNuclear medicine systems may show unintended radial detector motion during scans
FDA (Devices) · 2025-07-16
- HighPhilips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard
FDA (Devices) · 2025-04-30
- HighShimadzu Trinias Unity Catheterization Table Movement Control Defect
FDA (Devices) · 2024-10-30
- HighArctic Cat and Tracker Off-Road Vehicles Recalled for Crash Hazard
CPSC · 2024-10-17