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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Spineology, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0117-2025