Recall Z-0846-2024
XTANT Medical Holdings, Inc · initiated November 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Codes / lots: UDI-DI: 00810076564005, Lot: AP23000143
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.
FDA-determined cause: Process control
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).
Details
- Recall number
- Z-0846-2024
- Initiated
- November 28, 2023
- Posted by FDA
- January 29, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 6
- Distribution
- US distribution in MI.
- Recalling firm
- XTANT Medical Holdings, Inc, Belgrade, MT