Spineology, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0117-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 16, 2024

Date Posted: October 23, 2024

Recall Number: Z-0117-2025

Event ID: 95341

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.

Status: Ongoing

Product Quantity: 190 units

Code Information:

UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003

Distribution Pattern:

Pending

Voluntary or Mandated:

Voluntary: Firm initiated