RESTORIS, RIO 207080Recalls & reported problems
Mako Surgical Corp. · OFFSET CUP REAMER HANDLE · Class 2
All models of RESTORIS, RIO (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486022198), received between Nov 13, 2018 and Aug 15, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Non Reproducible Results” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Non Reproducible Results2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results
SCREW MISSING FROM OFFSET REAMER HANDLE. CASE TYPE: THA. AS PER THE MPS: "NO PATIENT INVOLVEMENT".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8898630 ↗MalfunctionNov 13, 2018Break; Non Reproducible Results; Break; Non Reproducible Results
THERE IS AN INTERNAL PIECE ON THE REAMER THAT'S BROKEN. THIS WAS A THA PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8064379 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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