CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report

TiBrid Stand Alone Intervertebral Body Fusion Device recalled

Omnia Medical is recalling TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30, distributed nationwide in the US. The recall was initiated on 15 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2556-2025
FDA event ID: 97402
Recalling firm: Omnia Medical, Morgantown, WV
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jul 2024
FDA classified: 11 Sep 2025
Reported: 17 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

15 Jul 2024	Recall initiated by company
11 Sep 2025	Classified by FDA	+423 days
17 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure of fusion system instruments in the field.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.

Nationwide Arizona California New Jersey Nevada Oklahoma Washington

Questions about this recall

Why was it recalled?

Failure of fusion system instruments in the field.

Which lots are affected?

Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97402

This product is part of a recall event; the main page for the event is TiBrid Stand Alone Intervertebral Body Fusion Device recalled.

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025	CLASS II	TiBrid Stand Alone Intervertebral Body Fusion Device recalled	Omnia Medical	Device Malfunction	Nationwide

More recalls from Omnia Medical

All 2

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Device	CLASS II	TiBrid Stand Alone Intervertebral Body Fusion Device recalled	Omnia Medical	Device Malfunction	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide