Cortera recallZ-0846-2024 · XTANT Medical Holdings, Inc · initiated Nov 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from XTANT Medical Holdings, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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).
Recall details
- Recall number
- Z-0846-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 28, 2023
- Posted by the FDA
- Jan 29, 2024
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 6
- Product code
- NKB
- FDA submissions
- K221403
- Distribution
- US distribution in MI.
Product description
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Code information (models, lots, serial numbers)
UDI-DI: 00810076564005, Lot: AP23000143
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cortera 150100-85050Xtant Medical Holdings, Inc. · Thoracolumbosacral pedicle screw system1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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