Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
This recall is currently active, issued January 29, 2024. It was issued by Xtant Medical Holdings, Inc.
- Company
- Xtant Medical Holdings, Inc
- Recall Initiated
- November 28, 2023
- Posted
- January 29, 2024
- Recall Number
- Z-0846-2024
- Quantity
- 6
- Firm Location
- Belgrade, MT
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution in MI.
Lot / Code Info
UDI-DI: 00810076564005, Lot: AP23000143
Root 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).