FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0117-2025
·
Reported October 23, 2024
Enforcement
- Recall Number
- Z-0117-2025
- Event ID
- 95341
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Spineology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 23, 2024
- Initiation Date
- September 16, 2024
- Classification Date
- October 17, 2024
- Address
- 7800 3rd St N Ste 600, Saint Paul, MN, 55128-5455, United States
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.
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.
Code Info
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Distribution
Pending
Quantity
190 units