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INSTRUMENT 6496-9-068Recalls & reported problems

Howmedica Osteonics Corp. · GMRS TIBIAL STYLUS · Class 1

All models of INSTRUMENT (131)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 07613327205695), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Device Markings/Labelling Problem1
  • Inaccurate Information1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 9, 2019Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

    THE TIBIAL STYLUS FROM THE GMRS ALL POLY PREPARATION TRAY SHOULD BE ENGRAVED WITH 12MM AND 18MM AS PER THE OPERATIVE TECHNIQUE. THE INSTRUMENT IN THE TRAY HAD THE CORRECT CATALOGUE NUMBER, BUT INSTEAD WAS ENGRAVED WITH 15MM AND 20MM. THE SURGEON WANTED A 12MM RESECTION, SO HAD TO USE THE 15MM MARKING, THEN MOVE THE BLOCK ON THE PINS TO RESECT 13MM OF TIBIA.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8977495 ↗

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Sources and updates

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