Carlsbad, CA, United States
Alphatec Spine, Inc. recalls
7 recalls recorded since 2018, most recently on 13 May 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)6
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 May 2026
- 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.
- Distribution
- US Nationwide distribution in the states of TX, MO, IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2793-2026
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Ongoing Class II Medical devices
- Recall started
- 2 January 2026
- Reason
- Due a design issue where the navigated array connection geometry is incorrect.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1343-2026, Z-1342-2026
- ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures
- ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures
Ongoing Class II Medical devices
- Recall started
- 15 December 2024
- Reason
- Complaints have been received regarding post-operative implant collapse.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1065-2025
- Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- Due to reports of intraoperative graft bolt implantation breakages.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1182-2024
- IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA
Ongoing Class II Medical devices
- Recall started
- 7 July 2023
- Reason
- Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
- Distribution
- US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2475-2023
- LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
Ongoing Class II Medical devices
- Recall started
- 14 September 2022
- Reason
- Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
- Distribution
- U.S.: CA O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0196-2023
- Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 1
Terminated Class II Medical devices
- Recall started
- 26 April 2021
- Terminated
- 17 November 2022
- Reason
- There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
- Distribution
- US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1818-2021, Z-1814-2021, Z-1817-2021, Z-1805-2021, Z-1803-2021, Z-1825-2021, Z-1809-2021, Z-1806-2021, Z-1822-2021, Z-1801-2021, Z-1811-2021, Z-1823-2021 and 17 more
- Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
- Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
- Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
- Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
- Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
- Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
- Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
- Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
- and 21 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.