ULTRA DRIVE III CONSOLE 423935Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304467293), received between Oct 1, 2019 and Oct 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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
- Device Displays Incorrect Message1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2019Device Displays Incorrect Message; Device Displays Incorrect Message
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE WAS REPORTED IN ERROR. THE INITIAL REPORT SHOULD BE VOIDED.
Patient problems: No Information
MAUDE report 9141178 ↗
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-1963-2019 · Jun 4, 2019 · TerminatedUltra-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-1962-2019 · Jun 4, 2019 · TerminatedUltra-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-1521-2012 · Apr 18, 2012 · TerminatedUltra-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
Other DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT devices
- Cascade IOMAX Intraoperative Monitor 190296-200Cadwell Industries, Inc. · DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT2 recalls0 reports
- ULTRA-DRIVE TOOL 423864Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA-DRIVE TOOL 423871Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA-DRIVE TOOL 423836Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA-DRIVE TOOL 423859Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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