Exact FDA event identifier

Event 95341

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: September 16, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Spineology, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0117-2025

Recall number: Z-0117-2025
Initiated: September 16, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Spineology, Inc.
Quantity: 190 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Pending