Reported Sep 17, 2025 · Ongoing

TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

Omnia Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Omnia Medical · 6 Canyon Rd Ste 300 · Morgantown, WV · 26508-9232

Is this the product you have?

  • TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl
  • Sizes
    • 30 degree
    • 45 degree and 60 degree
Lot codes and dates
    • Model No. 17-5A-AWL3
    • 17-5A-AWL4
    • 17-5A-AWL5
  • UDI
    • 00843511113056
    • 00843511122287
    • 00843511122294
Amount recalled
15 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Failure of fusion system instruments in the field.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.