RESTORIS, RIORecalls & reported problems across all models
Mako Surgical Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 665
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of RESTORIS, RIO by Mako Surgical Corp. in the FDA's device registry (GUDID). Together they are named in 665 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2018 and Sep 30, 2026 — classified as 2 injuries, 663 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (575 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RESTORIS, RIO problems
Device problems
- Detachment of Device or Device Component575
- Component Missing95
- Break50
- Non Reproducible Results32
- Fracture29
- Material Integrity Problem13
- Mechanical Problem13
- Material Fragmentation11
Patient problems
- No Clinical Signs, Symptoms or Conditions586
- No Known Impact Or Consequence To Patient77
- No Consequences Or Impact To Patient6
- Foreign Body In Patient2
- Injury1
RESTORIS, RIO models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RESTORIS, RIO 212760Orthopedic stereotaxic instrument605 reports
- RESTORIS, RIO 206270Orthopedic stereotaxic instrument54 reports
- RESTORIS, RIO 207084Orthopedic stereotaxic instrument4 reports
- RESTORIS, RIO 207080Orthopedic stereotaxic instrument2 reports
Recent RESTORIS, RIO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Screws loose Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943274 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935694 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931158 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930871 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930663 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
6/8 screws missing from one reamer shaft. 5/8 in the other. Neither will pass registration and Spd says they will not sterilize again Case Type / Application: THA 5.0
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896108 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
MalfunctionSep 25, 2026Detachment of Device or Device Component
6/8 screws missing from one reamer shaft. 5/8 in the other. Neither will pass registration and Spd says they will not sterilize again. Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896100 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
Failed to pass registration, successful after changing reamer shafts.Case Type / Application: THA 4.1 .Update - The device is missing two screws, causing it not to function.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866421 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858262 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Mako offset reamer lost screws Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858261 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Screw missing. Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858260 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Screw detached during post-procedure cleaning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855341 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Notice screws were missing from offset reamer during case set up. Case Type / Application: THA 4.1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799183 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following event was reported: "Mako THA case ¿ noted that screws were loose on the offset reamer following ¿ piece needs replacing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733268 ↗
Other Mako Surgical Corp. products
All Mako Surgical Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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