Mako RIO Standard System Recall: Intermittent Power Loss Risk
Mako Surgical recalls its RIO Standard System (P/N 201337) due to intermittent electrical issues that could cause power loss during orthopedic surgery. Affected units were sold with Lot No. 05212015.
Use caution until it’s fixed
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Contact the company
What happened, in plain English
Mako Surgical is recalling its RIO Standard System (P/N 201337) because a loose screw connection can cause intermittent power loss during surgery. This could disrupt critical software functions for orthopedic procedures. Read more at govinfonow.com/recall/73907-mako-rio-standard-system-recall-intermittent-power-loss-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73907-mako-rio-standard-system-recall-intermittent-power-loss-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2741-2017
Cite this page
“Mako RIO Standard System Recall: Intermittent Power Loss Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73907-mako-rio-standard-system-recall-intermittent-power-loss-risk. Based on FDA recall #Z-2741-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2741-2017%22&limit=1).
Why it’s dangerous
The system has a loose screw connection that can cause intermittent power loss. This might disrupt software-defined spatial boundaries during surgery, potentially affecting precision in orthopedic procedures.
Who’s affected
Surgeons using the Mako RIO Standard System for orthopedic procedures are most at risk. The recall applies to units with Lot No. 05212015.
How to tell if you have this one
Check for the product name 'Mako RIO Standard System' and part number 201337. Affected units were sold with Lot No. 05212015.
- Brand
Mako Surgical- Category
Medical device
What to do — step by step
Check System Status
Ensure the system remains powered on during surgery to avoid disruptions.
Where it went and when
Where it was distributed
Distributed in 17 states.
FDA distribution: “Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Massachusetts, Mississippi, Missouri, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 3 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.
Questions people ask
Is this recall dangerous?
The recall addresses a potential power loss risk during surgery, but the system may continue to function safely if properly monitored.
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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-2741-2017 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2741-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.