Alphatec Spine, Inc. recalls
Every recall we track for Alphatec Spine, Inc. — 36 in all, from 2021–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Alphatec Spine, Inc. peaked in 2021 (29); 36 since 2017.
All FDA recall records for Alphatec Spine, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 6 | 5 | 18 | 29 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 1 | 2 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 2 | 1 | 3 |
Most common reasons for Alphatec Spine, Inc. recalls
What to do if you have a recalled Alphatec Spine, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Alphatec Spine, Inc. recalls
7 shown- Lower riskMedical device
Alphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec recalls SafeOp Patient Interface (REF AIX11240) due to software issues that may cause system faults during surgery, potentially increasing operative time. Affected units have specific serial numbers.
AlphatecMay 13, 2026 - Lower riskMedical device
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;
Alphatec recalls specific LIF NAV Osteotome 10mm instruments due to incorrect navigated array connection geometry. These surgical tools may not function properly with Medtronic StealthStation systems.
AlphatecJan 2, 2026 - Lower riskMedical device
Alphatec Spine, Inc. recalls Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees,
Alphatec recalls Calibrate CCX interbody implants for spinal fusion due to reported post-operative collapse. Affected models include specific sizes and lot numbers. Check your implant details to determine if recalled.
AlphatecDec 15, 2024 - UnratedMedical device
Alphatec Spine, Inc. recalls IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x
Alphatec recalls specific IdentiTi ALIF graft bolts due to reports of breakage during spinal surgery. Affected units include certain part numbers and lot numbers. Consumers should contact Alphatec for details.
AlphatecJan 26, 2024 - Use cautionMedical device
Alphatec Spine, Inc. recalls LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF,
Alphatec recalls LIF AMP Adjustable Awl (REF 117-165) due to incorrect assembly causing dural tears and nerve damage during spine surgery. Affected units have UDI-DI 00190376228037 and lot EM50715.
Alphate:ecJul 7, 2023 - Lower riskMedical device
Alphatec Spine, Inc. recalls Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X
Alphatec recalls specific disc preparation instruments due to manufacturing issues that may require regulatory filing. Check product details to see if your item is affected.
AlphatecSep 14, 2022 - UnratedMedical device
Alphatec Spine, Inc. recalls Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI:
Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0354) due to potential screw mechanism disassociation post-surgery. Affected patients should contact the company for details.
AlphatecApr 26, 2021
Alphatec Spine, Inc. recall questions
How many recalls has Alphatec Spine, Inc. had?
36 recalls from Alphatec Spine, Inc. are on record with U.S. safety agencies, from 2021–2026.
What is the most recent Alphatec Spine, Inc. recall?
Alphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System, dated May 13, 2026. Every Alphatec Spine, Inc. recall is listed on this page, newest first.
Why are Alphatec Spine, Inc. products recalled?
The most common reasons on record: Due a design issue where the navigated array connection geometry is incorrect. (2).
What should I do if I have a recalled Alphatec Spine, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Alphatec Spine, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.