Z-2556-2025Class II

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

Name: Z-2556-2025 TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60...
Creator: Omnia Medical
Published: 2024-07-15
License: https://open.fda.gov/license/

Omnia Medical / initiated 2024-07-15 / Open, Classified / root cause: design

FDA source

Omnia Medical began a recall of TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree on 2024-07-15. FDA classified it as Class II and gives the reason as "Failure of fusion system instruments in the field". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2556-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-15
Posted: 2025-09-11
Recalling firm: Omnia Medical
Product: TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Failure of fusion system instruments in the field.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability.
Quantity in commerce: 15 units
Distribution: US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Product codes and lots: Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2556-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2556-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11
Z-2557-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11

Product code OVD

K203207Class IIOmnia Medical TiBrid-SAOmnia Medical, LLC / cleared 2020-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)