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Alphatec Spine, Inc. FDA Recalls
36 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemClass IIMay 13, 2026Intraoperative neuromonitoring device, due to a software iss |
| ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;Class IIJan 2, 2026Due a design issue where the navigated array connection geom |
| ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;Class IIJan 2, 2026Due a design issue where the navigated array connection geom |
| Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 dClass IIDec 15, 2024Complaints have been received regarding post-operative impla |
| IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 xClass IIJan 26, 2024Due to reports of intraoperative graft bolt implantation bre |
| LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, TClass IIJul 7, 2023Awl instrument adjustable drill button assembly assembled in |
| Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A Class IISep 14, 2022Due to manufacturing instruments which included additional f |
| Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (0Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |
| Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01Class IIApr 26, 2021There is a potential for the screw blocking mechanism on the |