The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced t
Summary
The FDA issued a Class II for The Graft Tube is an optional instrument which, as designed, can be filled with by Spineology, Inc.. 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..
Details
Source
Device Recall
External ID
Z-0117-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Quantity Affected: 190 units
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.
Distribution
Pending
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-16
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spineology, Inc. has 6 FDA actions in our database, including 1 recall and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spineology, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spineology, Inc. have FDA actions?
Spineology, Inc. has 6 FDA actions in our database, including 1 recall and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0117-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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