Recall Z-0117-2025 ยท LXH Orthopedic Manual Surgical Instrument
Spineology, Inc.
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.
| Date | Oct 17, 2024 (initiated Sep 16, 2024) |
| Status | Open, Classified |
| Reason | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 190 units |
| Distribution | Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.