Alphatec Spine recalls
6 official recalls and safety alerts involving Alphatec Spine since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Alphatec Spine or the relevant agency.
- 2026-07-29
USAlphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
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…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of TX, MO, IN.Official notice →- 2026-02-18
- US
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC…
Due a design issue where the navigated array connection geometry is incorrect.
FDA · DeviceAlphatec Spine, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO,…Official notice → - 2025-02-05
- US
Alphatec Spine, Inc. recalls Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505,…
Complaints have been received regarding post-operative implant collapse.
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL,…Official notice → - 2024-03-06
- US
Alphatec Spine, Inc. recalls 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…
Due to reports of intraoperative graft bolt implantation breakages.
FDA · DeviceAlphatec Spine, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AZ,…Official notice → - 2023-09-06
- US
Alphatec Spine, Inc. recalls LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and…
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…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA,…Official notice → - 2022-11-16
- US
Alphatec Spine, Inc. recalls Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm,…
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.