FDA Medical Device Recalls (openFDA)
Spineology, Inc.: The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
- Recall number
- Z-0117-2025
- Recalling firm
- Spineology, Inc.
- Product
- The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
- Status
- Open, Classified
- Initiated
- 2024-09-16
- Posted
- 2024-10-17
- Terminated
- not on file
- Reason
- Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- Root cause
- Under Investigation by firm
- Action
- Spineology began notification of medical institutions on 09/16/2024, direct sales representatives on 09/18/2024 and distributors on 09/19/2024 via letter. Instructions included to notify appropriate staff of the action and to complete and return the response form. Spineology will be performing a correction to update the surgical technique labeling and a removal will be conducted to replace current Graft Tubes within field inventory. Distributors were instructed to notify customers if further distributed.
- Quantity
- 190 units
- Distribution
- Pending
- Lot, serial or model codes
- UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003179719
- Firm city
- Saint Paul
- Firm state
- MN
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06