Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
FDA device recall Z-0846-2024 · posted 2024-01-29 · Open, Classified
Recall details
- Recalling firm
- XTANT Medical Holdings, Inc
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 6
- Distribution
- US distribution in MI.
- Date initiated
- 2023-11-28
- Date posted
- 2024-01-29
- Location
- Belgrade, MT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cortera Spinal Fixation System (K221403) | Surgalign Spine Technologies | 2022-08-19 |