FDA Medical Device Recalls (openFDA)
XTANT Medical Holdings, Inc: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Recall number
- Z-0846-2024
- Recalling firm
- XTANT Medical Holdings, Inc
- Product
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Status
- Open, Classified
- Initiated
- 2023-11-28
- Posted
- 2024-01-29
- Terminated
- not on file
- 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.
- Root cause
- Process control
- 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).
- Quantity
- 6
- Distribution
- US distribution in MI.
- Lot, serial or model codes
- UDI-DI: 00810076564005, Lot: AP23000143
- 510(k) numbers
- ["K221403"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3005031160
- Firm city
- Belgrade
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28