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.
Reported: October 23, 2024 Initiated: September 16, 2024 #Z-0117-2025
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.
Details
- Recalling Firm
- Spineology, Inc.
- Units Affected
- 190 units
- Distribution
- Pending
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spineology, Inc.. Units affected: 190 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0117-2025.
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