Recall Z-0117-2025
Spineology, Inc. · initiated September 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
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.
FDA-determined cause: Under Investigation by firm
Action taken
Spineology began notification of medical institutions on 09/16/2024, direct sales representatives on 09/18/2024 and distributors on 09/19/2024 via letter. Instructions included to notify appropriate staff of the action and to complete and return the response form. Spineology will be performing a correction to update the surgical technique labeling and a removal will be conducted to replace current Graft Tubes within field inventory. Distributors were instructed to notify customers if further distributed.
Details
- Recall number
- Z-0117-2025
- Initiated
- September 16, 2024
- Posted by FDA
- October 17, 2024
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 190 units
- Distribution
- Pending
- Recalling firm
- Spineology, Inc., Saint Paul, MN