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ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT 1 (REF 99-93568)Recalls & reported problems

Orthofix Srl · POWER DRILL TORQUE LIMITER · Class 2

All models of ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

  1. Jul 5, 2017Class IITerminated

    The power drill torque limiter may break during use in surgery application.

    Z-0291-2018 · Root cause: Process change control · Recall details · FDA record ↗

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Sources and updates

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