FDA Medical Device Recalls (openFDA)
Omnia Medical: TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Recall number
- Z-2556-2025
- Recalling firm
- Omnia Medical
- Product
- TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Status
- Open, Classified
- Initiated
- 2024-07-15
- Posted
- 2025-09-11
- Terminated
- not on file
- Reason
- Failure of fusion system instruments in the field.
- 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
- 15 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
- Lot, serial or model codes
- Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
- 510(k) numbers
- ["K203207"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3010560653
- Firm city
- Morgantown
- Firm state
- WV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28