The Recall Desk
HighFDA (Devices)·Z-0117-2025·Announced 2024-10-23

Graft Tube shaft may detach from funnel head during surgical use

Spineology is recalling 190 Graft Tubes because the shaft may detach from the funnel head when not used as instructed, potentially compromising spinal surgical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a potential structural defect (shaft detachment) in a surgical instrument. No injuries or illnesses have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

The FDA is recalling Spineology's Graft Tube, a surgical instrument used during spinal procedures to deploy flowable graft material. The device is filled with graft material, advanced through an Access Portal, and used with a Push Rod to facilitate manual deployment. The recalled units are identified by lot numbers CH20003 and BE22003, totaling 190 units.

The Graft Tube shaft may detach from the funnel head when the device is not used as instructed according to the manufacturer's Surgical Technique Guide. This potential detachment could compromise the surgical procedure.

The recalled product

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 impl
Manufacturer
Spineology, Inc.
Category
Medical Device — Surgical instrument / Spinal
Hazard
Affected units
190

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · component detachment

See all →