NAVIO ROB00025Recalls & reported problems
Smith & Nephew, Inc. · NAVIO Total Knee Arthroplasty LEFT TIBIA TWIN PEG CUT GUIDE · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556684917), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE PIN GOT STUCK IN THE NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE. THEY WERE ABLE TO GET THE PIN OUT, BUT COULD NOT GET ANOTHER PIN TO PASS THROUGH. THEREFORE, THEY USED A DIFFERENT PIN HOLE TO ON THE BLOCK. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.
Patient problems: Unspecified Tissue Injury
MAUDE report 12844206 ↗
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- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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