FDA Medical Device Recalls (openFDA)
Alphatec Spine, Inc.: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Recall number
- Z-2793-2026
- Recalling firm
- Alphatec Spine, Inc.
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Status
- Open, Classified
- Initiated
- 2026-05-13
- Posted
- 2026-07-23
- Terminated
- not on file
- Reason
- Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
- Root cause
- Software Design Change
- Action
- On 5/13/2026, recall notices were emailed to customers who were advised of the following: 1) Recalling firm has provided replacement SafeOp 3 Systems. 2) Abstain from using affected devices and return to recalling firm. 3) Share this notice within your organization or any organization where the affected device(s) has(have) been transferred. 4) Fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions, as described in this notification. If you have any questions/concerns or require assistance with the recall, please e-mail QMSCompliance@atecspine.com or call 1-800-922-1356.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Lot, serial or model codes
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- 510(k) numbers
- ["K252842"]
- PMA numbers
- not on file
- Product code
- GWF
- Firm FEI
- 2027467
- Firm city
- Carlsbad
- Firm state
- CA
- 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