Z-0117-2025Class II

The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then...

Name: Z-0117-2025 The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then...
Creator: Spineology, Inc.
Published: 2024-09-16
License: https://open.fda.gov/license/

Spineology, Inc. / initiated 2024-09-16 / Open, Classified

FDA source

Spineology, Inc. began a recall of 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... on 2024-09-16. FDA classified it as Class II and gives the reason as "Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0117-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-16
Posted: 2024-10-17
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
FDA 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 in commerce: 190 units
Distribution: Pending
Product codes and lots: UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0117-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)