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ULTRA-DRIVE TOOL 423864Recalls & reported problems

Biomet Orthopedics, LLC · 5 MM HOE · Class 2

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 00880304372979), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K031280); they may or may not involve this specific model.

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

  • Fracture1

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.

  • MalfunctionMar 26, 2020Fracture; Fracture

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE PRODUCTS BENT, TWISTED AND FRACTURED DURING USE. IT IS UNKNOWN IF THERE WAS ANY HARM OR INJURY SUSTAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9883047 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031280. One submission often covers many models, so check the product and lot details in each record.

  • Z-1962-2019 · Jun 4, 2019 · Terminated
    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone a
  • Z-1963-2019 · Jun 4, 2019 · Terminated
    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of
  • Z-1521-2012 · Apr 18, 2012 · Terminated
    Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter

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Sources and updates

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