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TiBrid-SA 17-5A-DV60Recalls & reported problems

Omnia Medical, LLC · 60 Degree Flex Tube Driver · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K203207); 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.

Recalls naming this device

  1. Jul 15, 2024Open, Classified

    Failure of fusion system instruments in the field.

    Z-2557-2025 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203207. One submission often covers many models, so check the product and lot details in each record.

  • Z-2556-2025 · Jul 15, 2024 · Open, Classified
    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices

All Intervertebral Fusion Device With Integrated Fixation, Lumbar devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page