Recall Z-0125-2025 ยท NKB Thoracolumbosacral Pedicle Screw System
XTANT Medical Holdings, Inc
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
| Date | Oct 17, 2024 (initiated Aug 21, 2024) |
| Status | Open, Classified |
| Reason | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance. |
| Root cause | Process change control |
| Action | On 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to mdolan@xtantmedical.com |
| Quantity | 330 |
| Distribution | US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221403 | Cortera Spinal Fixation System Surgalign Spine Technologies, Aug 19, 2022 |