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NA 111770Recalls & reported problems

Mako Surgical Corp. · KNEE END EFFECTOR · Class 2

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 00848486000042), received between Jan 11, 2019 and Jul 3, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Non Reproducible Results2
  • Component Missing1
  • 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.

  • MalfunctionJul 3, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

    O-RING IS MISSING. CASE TYPE: PKA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8757655 ↗
  • MalfunctionJan 11, 2019Component Missing; Non Reproducible Results; Component Missing; Non Reproducible Results

    THE SMALL MAGNET THAT IS ON THE UNDERSIDE OF THE TRIGGER IS NOT THERE. THIS CAUSED FOR THE ANSPACH NOT TO COME ON. THIS IS A LOANER SET THAT I RECEIVED. CASE TYPE: PKA. SURGICAL DELAY: 5 MIN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8239450 ↗

Other Orthopedic stereotaxic instrument devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.