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Spineology, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Spineology, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-23FDA-DeviceClass IIThe 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.
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
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