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RESTORIS 120095Recalls & reported problems

Mako Surgical Corp. · TIBIAL ONLAY CEMENT REMOVAL TOOL · 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 00848486018092), received between Aug 20, 2018 and May 31, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Fracture1
  • Material Twisted/Bent1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 31, 2019Break; Fracture; Break; Fracture

    THE CEMENT SCRAPER WAS BEING USED TO PICK A PIECE OF HARD CEMENT OFF AND WAS BENT, UPON TRYING TO RETURN IT TO ITS NORMAL SHAPE, THE END OF THE SCRAPER BROKE OFF. CASE TYPE: TKA.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8658162 ↗
  • MalfunctionAug 20, 2018Material Twisted/Bent; Material Twisted/Bent

    THE CEMENT TOOL BENT INTRAOP. CASE TYPE: PKA

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7797133 ↗

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