NA 111650Recalls & reported problems
Mako Surgical Corp. · CHECKPOINT KIT · Class 2 · Implant
Data updated Oct 13, 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 00848486001346), received between Dec 18, 2018 and Dec 18, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
- Non Reproducible Results2
- Material Integrity Problem1
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.
MalfunctionDec 18, 2018Break; Material Integrity Problem; Non Reproducible Results; Break; Material Integrity Problem; Non Reproducible Results
TIBIAL CHECKPOINT TIP BROKE OFF WHEN REMOVING IT, A SMALL PIECE WAS LEFT IN THE BONE AND SURGEON COULD NOT RETRIEVE IT. THE REMAINDER HAS BEEN RETURNED. SECOND TIBIAL CHECKPOINT USED ALSO BENT ON INSERTION AND HAS ALSO BEEN RETURNED. THE PROCEDURE WAS A LEFT TKA MAKO. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8177266 ↗MalfunctionDec 18, 2018Break; Non Reproducible Results; Break; Non Reproducible Results
TIBIAL CHECKPOINT TIP BROKE OFF WHEN REMOVING IT, A SMALL PIECE WAS LEFT IN THE BONE AND SURGEON COULD NOT RETRIEVE IT. THE REMAINDER HAS BEEN RETURNED. SECOND TIBIAL CHECKPOINT USED ALSO BENT ON INSERTION AND HAS ALSO BEEN RETURNED. THE PROCEDURE WAS A LEFT TKA MAKO. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8177263 ↗
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- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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