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NA 112660Recalls & reported problems

Mako Surgical Corp. · ARRAY STABILIZER 4.0 LONG · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486017880), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

  • Physical Resistance/Sticking1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    WHEN INSERTING THE SECOND FEMORAL PIN 4X170 IT GOT STUCK TO THE STABILIZER. CASE TYPE: TKA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9765064 ↗

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