Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
FDA device recall Z-0125-2025 · posted 2024-10-17 · Open, Classified
Recall details
- Recalling firm
- XTANT Medical Holdings, Inc
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 330
- Distribution
- US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
- Date initiated
- 2024-08-21
- Date posted
- 2024-10-17
- Location
- Belgrade, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cortera Spinal Fixation System (K221403) | Surgalign Spine Technologies | 2022-08-19 |