FDA Recall
Open, Classified
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Recall: Z-0846-2024
·
Initiated November 28, 2023
Recall
- Recall Number
- Z-0846-2024
- Event Number
- 93738
- Firm
- XTANT Medical Holdings, Inc
- FEI Number
- 3005031160
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 28, 2023
- Posted
- January 29, 2024
- Address
- 664 Cruiser Ln, Belgrade, MT, 59714-9719
Description
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Reason
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
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).
Distribution
US distribution in MI.
Quantity
6