FDA Medical devices recall ·
The Graft Tube is an optional instrument which, as designed… recall
- Recall number
- Z-0117-2025
- Date
- (initiated September 16, 2024)
- Company / brand
- Spineology, Inc.
7800 3rd St N Ste 600, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 190 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Distribution
Pending
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0117-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.