Cortera recallZ-0125-2025 · XTANT Medical Holdings, Inc · initiated Aug 21, 2024
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 system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
FDA root cause category: Process change control
What the company is doing
On 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to [email protected]
Recall details
- Recall number
- Z-0125-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 21, 2024
- Posted by the FDA
- Oct 17, 2024
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 330
- Product code
- NKB
- FDA submissions
- K221403
- Distribution
- US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Product description
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Code information (models, lots, serial numbers)
UDI-DI: 00810076563190, Lot: DNI
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cortera 150100-65045Xtant Medical Holdings, Inc. · Thoracolumbosacral pedicle screw system1 recall2 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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