Recall Z-0846-2024 ยท NKB Thoracolumbosacral Pedicle Screw System
XTANT Medical Holdings, Inc
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
| Date | Jan 29, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging. |
| Root cause | Process control |
| Action | On 11/28/23 the recall notice was emailed. Customers with questions can call the firm at 1-406-924-5878 from 8 a.m. to 5 p.m. (Mountain Time). |
| Quantity | 6 |
| Distribution | US distribution in MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221403 | Cortera Spinal Fixation System Surgalign Spine Technologies, Aug 19, 2022 |