Z-0117-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- September 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
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.
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 Pattern
Pending
Code Information
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003