Mako Surgical Rio System Irrigation Clip Recall: Out of Tolerance Hazard
Mako Surgical recalls Rio System Irrigation Clip (Catalog #111690) for out of tolerance risk in RESTORIS Partial Knee Application procedures. Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
Recall notice
Out of tolerance.
Contact the company
What happened, in plain English
Mako Surgical is recalling the Rio System Irrigation Clip (Catalog #111690) used with RESTORIS Partial Knee Application procedures. The recall is due to a risk of being out of tolerance, which could affect surgical accuracy during knee procedures. This is a critical safety issue for surgeons using the device. Read more at govinfonow.com/recall/71151-mako-surgical-rio-system-irrigation-clip-recall-out-of-tolerance.
Source Summary by GovInfoNow · govinfonow.com/recall/71151-mako-surgical-rio-system-irrigation-clip-recall-out-of-tolerance · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2794-2018
Cite this page
“Mako Surgical Rio System Irrigation Clip Recall: Out of Tolerance Hazard.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71151-mako-surgical-rio-system-irrigation-clip-recall-out-of-tolerance. Based on FDA recall #Z-2794-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2794-2018%22&limit=1).
Why it’s dangerous
The clip is designed to assist surgeons in providing software-defined spatial boundaries during orthopedic procedures. Being out of tolerance could lead to inaccurate surgical reference points, potentially causing errors in knee replacements.
Who’s affected
Surgeons using the Rio System Irrigation Clip with RESTORIS Partial Knee Application procedures are affected. The most at-risk users are those operating on patients with unicondylar or patellofemoral knee replacements.
How to tell if you have this one
Check for the Rio System Irrigation Clip with Catalog #111690 used in RESTORIS Partial Knee Application procedures. Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
- Brand
Mako Surgical- Category
Medical device
What to do — step by step
Check Product Lot Number
Identify the lot number on the Rio System Irrigation Clip to see if it matches the affected lots listed: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, or 195763A1.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 41 states.
FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.7 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-2794-2018 (May 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2794-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 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.