Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The RIO (TGS 2.) Recalled by Mako Surgical Corporation Due to MAKO Surgical Group recalled their RIO System software,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mako Surgical Corporation directly.
Affected Products
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 surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
Quantity: 137 devices
Why Was This Recalled?
MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
Where Was This Sold?
This product was distributed to 33 states: AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, MD, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WV, WI
About Mako Surgical Corporation
Mako Surgical Corporation has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report