Mako Surgical RIO Robotic System Software Issue: Missing EE Constants
Mako Surgical recalls Robotic Arm Interactive Orthopedic System (RIO) due to software not displaying all EE constants when screen is full. Affected units may have incomplete surgical guidance.
Recall notice
Software discrepancy of not showing all the EE constants, when the screen is filled.
Contact the company
What happened, in plain English
Mako Surgical is recalling their Robotic Arm Interactive Orthoped: RIO system because software fails to show all EE constants when the screen is full. This could lead to incomplete surgical guidance during procedures. Read more at govinfonow.com/recall/73172-mako-surgical-rio-robotic-system-software-issue-missing-ee-constants.
Source Summary by GovInfoNow · govinfonow.com/recall/73172-mako-surgical-rio-robotic-system-software-issue-missing-ee-constants · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3130-2017
Cite this page
“Mako Surgical RIO Robotic System Software Issue: Missing EE Constants.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73172-mako-surgical-rio-robotic-system-software-issue-missing-ee-constants. Based on FDA recall #Z-3130-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3130-2017%22&limit=1).
Why it’s dangerous
The software doesn't display all EE constants when the screen is full, which could cause incomplete surgical guidance. This might lead to errors in anatomical reference during procedures.
Who’s affected
Surgeons using the RIO system for partial knee procedures may be affected. Those with the specific lot codes are most at risk.
How to tell if you have this one
Check for the RIO system used in partial knee procedures. Affected units have specific lot codes that are listed in the recall notice.
- Brand
Mako Surgical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3130-2017 | 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 procedures.; All Lot codes | 349 (US) and 78 (OUS) |
| Z-3131-2017 | 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.; All Lot codes | 291 (US) and 66 (OUS) |
What to do — step by step
Check Product Lot Code
Identify the lot code on your RIO system to determine if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
FDA distribution: “Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3130-2017 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3130-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.