RI.KNEE Tibia Fixation Base Right 4240-7502Recalls & reported problems
Enztec Limited · A reusable surgical instrument intended to be used during an orthopaedic surgical procedure · Class 2
Data updated Oct 18, 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 09421028118200), received between Nov 29, 2024 and Dec 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure2
- Fracture1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2024Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam
IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE SURGEON FIXATED A PIN INTO THE PIN HOLE OF THE RI. KNEE TIBIA FIXATION BASE RIGHT AND WHEN EXTRACTING THE PIN, THE PIN GOT STUCK AND THE HEAD OF THE PIN BROKE OFF WITHOUT EXCESSIVE FORCE WHICH CAUSED THE PIN TO GET STUCK IN THE HOLE, THE PIND DID NOT FRACTURE. THE DEVICE WAS BEING TAKEN OUT WHEN THE PIN GOT STUCK, THE DEVICE WAS NO LONGER NEEDED AND NO LONGER USED. SURGERY WAS RESUMED WITHOUT ANY DELAY. PATIENT IS HEALTHY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026787 ↗MalfunctionNov 29, 2024Fracture; Separation Failure; Fracture; Separation Failure
IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY; AFTER PREPPING THE FEMUR THE SURGEON WENT TO NAVIGATE THE TIBIA CUT. WHILE HE WAS TRYING TO RAISE THE ADJUSTABLE TIBIA GUIDE, THEY TURNED THE KNOB TO THE WRONG DIRECTION. THEY BOTTOMED OUT THE ADJUSTABLE TIBIA GUIDE AND KEPT TWISTING THE KNOB TO THE LEFT UNTIL THE KNOB BROKE OFF. NOW THE ADJUSTABLE TIBIA GUIDE AND THE FIXATION BASE ARE STUCK TOGETHER BECAUSE THE KNOB BROKE OFF. THE CASE WAS COMPLETED ROBOTICALLY, BUT THE SURGEON ENDED UP BURRING THE WHOLE TIBIA CUT INSTEAD OF NAVIGATING THE CUT WITH THE PLANE VISUALIZER. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20808921 ↗
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- 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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