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TiBrid-SA 17-5A-AWL5Recalls & reported problems

Omnia Medical, LLC · Awl, 60 Degrees · Class 2

Data updated Oct 18, 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 18, 2026.

Recalls naming this device

  1. Jul 15, 2024Class IIOpen, Classified

    Failure of fusion system instruments in the field.

    Z-2556-2025 · 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-2557-2025 · Jul 15, 2024 · Open, Classified
    TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

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