Mako Surgical: Makoplasty RIO Standard System Recall for Communication Errors
Mako Surgical recalls Makoplasty RIO Standard System (Ethernet to Fiber Optic Converter) due to communication-connection errors in partial knee surgery. Affected units include all lots for the Partial Knee Application.
Recall notice
Communication-connection error.
Contact the company
What happened, in plain English
Mako Surgical is recalling its Makoplasty RIO Standard System (Ethernet to Fiber Opt: Converter) for potential communication errors during partial knee surgery. This recall affects all units sold for the Partial Knee Application, which is used in specific surgical procedures. Read more at govinfonow.com/recall/72221-mako-surgical-makoplasty-rio-standard-system-recall-for-communication-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/72221-mako-surgical-makoplasty-rio-standard-system-recall-for-communication-errors · Updated August 31, 2026 · FDA enforcement record: FDA #Z-3182-2018
Cite this page
“Mako Surgical: Makoplasty RIO Standard System Recall for Communication Errors.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72221-mako-surgical-makoplasty-rio-standard-system-recall-for-communication-errors. Based on FDA recall #Z-3182-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3182-2018%22&limit=1).
Why it’s dangerous
The system uses Ethernet to fiber optic converters for surgical guidance. A communication-connection error could disrupt the system's ability to accurately guide the surgery, potentially leading to incorrect bone alignment or procedure errors.
Who’s affected
Surgical teams using the Makoplasty RIO Standard System for partial knee replacements are affected. Patients undergoing these procedures with the system are at risk if the communication error occurs.
How to tell if you have this one
Check for the Makoplasty RIO Standard System with Catalog # 200933. This product is used for the Partial Knee Application in surgical knee procedures. All lots are affected.
- Brand
Mako Surgical- Category
Medical device
What to do — step by step
Check Product Details
Identify the product by checking for Catalog # 200933 and the Partial Knee Application label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
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.
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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-3182-2018 (December 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3182-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 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.