Alphatec Spine, Inc.
Medical device manufacturer in Carlsbad, CA.
101510(k) clearances
0PMA approvals
57recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 21
- NKB Thoracolumbosacral Pedicle Screw System 20
- KWQ Appliance, Fixation, Spinal Intervertebral… 9
- OLO Orthopedic Stereotaxic Instrument 7
- MNI Orthosis, Spinal Pedicle Fixation 6
- OVD Intervertebral Fusion Device With… 5
- KWP Appliance, Fixation, Spinal Interlaminal 4
- ODP Intervertebral Fusion Device With Bone… 4
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- GWF Stimulator, Electrical, Evoked Response 3
- NKG Posterior Cervical Screw System 3
- PDQ Neurosurgical Nerve Locator 3
- PHM Intervertebral Fusion Device With Bone… 2
- MRW System, Facet Screw Spinal Device 2
- MQP Spinal Vertebral Body Replacement Device 2
- OVE Intervertebral Fusion Device With… 1
- LLZ System, Image Processing, Radiological 1
- PML Bone Cement, Posterior Screw Augmentation 1
- OWB Interventional Fluoroscopic X-Ray System 1
- OWI Bone Fixation Cerclage, Sublaminar 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | 07/14/2026SE |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending SystemSIN · Traditional | 06/25/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | 03/25/2026SE |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional | 02/19/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | 01/11/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | 09/03/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
| K243461 | Calibrate Interbody Systems · Traditional | 03/04/2025SE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional | 02/03/2025SE |
| K242364 | IdentiTi II Interbody SystemMAX · Traditional | 10/04/2024SE |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAX · Traditional | 09/20/2024SE |
| K241519 | Invictus® Small Stature Spinal Fixation SystemNKB · Traditional | 06/21/2024SE |
| K240951 | Invictus Robotic Navigation InstrumentsOLO · Traditional | 06/06/2024SE |
| K240199 | IntraOp Alignment SystemOWB · Traditional | 05/22/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | 04/19/2024SE |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…KWQ · Traditional | 02/22/2024SE |
| K232345 | ATEC Posterior Navigated Disc Prep InstrumentsOLO · Traditional | 11/02/2023SE |
| K232504 | Calibrate CCX Interbody SystemMAX · Traditional | 10/13/2023SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | 10/06/2023SE |
| K232044 | Invictus Robotic Navigation InstrumentsOLO · Traditional | 10/06/2023SE |
| K232275 | Invictus® Spinal Fixation SystemNKB · Traditional | 09/27/2023SE |
| K232097 | IdentiTi ALIF Interbody SystemsOVD · Traditional | 09/25/2023SE |
| K232413 | Fusion Robotic Navigation SystemOLO · Special | 09/08/2023SE |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemMAX · Traditional | 07/13/2023SE |
| K230721 | ATEC Lateral Plate SystemKWQ · Traditional | 05/09/2023SE |
| K223611 | Calibrate LTX Interbody SystemMAX · Traditional | 03/29/2023SE |
| K223765 | ATEC Lateral Navigation InstrumentsOLO · Traditional | 03/23/2023SE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemPML · Traditional | 12/20/2022SE |
| K222455 | Calibrate LTX Interbody SystemMAX · Traditional | 11/18/2022SE |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…ODP · Traditional | 11/17/2022SE |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend…MAX · Traditional | 10/07/2022SE |
| K221821 | ATEC IOM Accessory InstrumentsPDQ · Traditional | 09/23/2022SE |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend…MAX · Traditional | 06/09/2022SE |
| K214006 | Invictus® Spinal Fixation SystemNKB · Traditional | 04/04/2022SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | 03/09/2022SE |
| K213443 | Insignia Anterior Cervical Plate SystemKWQ · Traditional | 12/15/2021SE |
| K213460 | Invictus Spinal Fixation SystemNKB · Traditional | 12/10/2021SE |
| K211987 | ATEC Alignment AppLLZ · Traditional | 10/29/2021SE |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…MAX · Traditional | 09/22/2021SE |
| K211873 | PSX Interbody SystemMAX · Traditional | 08/10/2021SE |
| K203742 | IdentiTi ALIF Standalone Interbody SystemOVD · Traditional | 04/09/2021SE |
| K203125 | Invictus OCT Spinal Fixation SystemNKG · Traditional | 12/18/2020SE |
| K202812 | IdentiTi Cervical Standalone Interbody SystemOVE · Traditional | 12/18/2020SE |
| K203056 | Invictus Spinal Fixation SystemNKB · Traditional | 11/23/2020SE |
| K202587 | ATEC Lateral Interbody SystemMAX · Traditional | 11/06/2020SE |
| K202327 | Invictus OsseoScrew® SystemNKB · Traditional | 10/15/2020SE |
| K200936 | Invictus CT Spinal Fixation SystemNKG · Traditional | 05/22/2020SE |
| K200995 | Insignia Anterior Cervical Plate SystemKWQ · Traditional | 05/21/2020SE |
| K192938 | Invictus Spinal Fixation SystemNKB · Traditional | 12/12/2019SE |
| K191723 | ATEC IOM Accessory InstrumentsPDQ · Traditional | 10/18/2019SE |
| K191311 | ATEC Lateral Interbody SystemMAX · Traditional | 08/12/2019SE |
| K191185 | Solanas® Posterior OCT Fixation SystemNKG · Traditional | 06/03/2019SE |
| K182617 | ATEC IOM Accessory InstrumentsPDQ · Traditional | 05/09/2019SE |
| K183705 | IdentiTi Porous Ti Interbody SystemMAX · Traditional | 03/01/2019SE |
| K182746 | ATEC ALIF and LLIF Spacer SystemMAX · Traditional | 11/27/2018SE |
| K182808 | Aspida® Anterior Lumbar Plating SystemKWQ · Traditional | 11/09/2018SE |
| K181980 | OsseoScrew SystemNKB · Traditional | 09/25/2018SE |
| K181435 | ATEC Cervical Spacer SystemODP · Traditional | 08/21/2018SE |
| K181677 | Kodiak Spinal Fixation SystemNKB · Traditional | 08/09/2018SE |
| K181453 | ATEC ALIF Spacer SystemMAX · Traditional | 07/25/2018SE |
| K180480 | ATEC Universal Spacer SystemPHM · Traditional | 05/31/2018SE |
| K173522 | Solanas® Posterior Stabilization SystemNKB · Special | 11/30/2017SE |
| K160958 | Battalion Universal Spacer SystemPHM · Traditional | 09/08/2016SE |
| K160646 | XYcor® Expandable Spinal Spacer SystemMAX · Traditional | 08/24/2016SE |
| K161363 | Arsenal Spinal Fixation SystemNKB · Special | 06/10/2016SE |
| K153603 | Alphatec Navigation InstrumentsOLO · Traditional | 04/29/2016SE |
| K152968 | Arsenal Spinal Fixation SystemNKB · Traditional | 12/30/2015SE |
| K143740 | Battalion Universal Spacer SystemMAX · Traditional | 05/22/2015SE |
| K143149 | Arsenal Spinal Fixation SystemNKB · Special | 01/05/2015SE |
| K133221 | Arsenal Spinal Fixation SystemNKB · Traditional | 03/13/2014SE |
| K131119 | Solanas Posterior Stabilization SystemNKB · Special | 05/21/2013SE |
| K130548 | Epicage Interbody Fusion DeviceMAX · Special | 04/18/2013SE |
| K123993 | Solus Anterior Lumbar Interbody Fusion (Alif) SystemOVD · Traditional | 03/05/2013SE |
| K123623 | Illico Mis Posterior Fixation SystemNKB · Traditional | 02/14/2013SE |
| K123218 | Illico FS Facet Fixation SystemMRW · Special | 11/28/2012SE |
| K111634 | Xenon(Tm) Pedicle Screw SystemNKB · Traditional | 01/25/2012SE |
| K110170 | Raptor Facet Fixation SystemMRW · Traditional | 11/28/2011SE |
| K111076 | Solanas Avalon Posterior Fixation SystemNKB · Traditional | 07/12/2011SE |
| K103205 | Bridgepoint Spinous Process Camp- Posterior Fixation SystemKWP · Traditional | 06/02/2011SE |
| K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemOVD · Traditional | 03/30/2011SE |
| K102820 | Appliance, Fixation, Spinal Intervertebral BodyKWQ · Traditional | 11/05/2010SE |
| K101255 | Alphatec Spine Anterior Lumbar Plating SystemKWQ · Traditional | 07/21/2010SE |
| K100685 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | 06/18/2010SE |
| K100138 | Zodiac Polyaxial Spinal Fixation SystemMNI · Special | 02/17/2010SE |
| K093077 | Zodiac Polyaxial Spinal Fixation SystemMNI · Special | 12/23/2009SE |
| K091189 | Zodiac Polyaxial Spinal Fixation SystemMNI · Special | 07/08/2009SE |
| K090779 | Zodiac Polyaxial Spinal Fixation SystemMNI · Special | 07/07/2009SE |
| K090425 | Guided Lateral Interbody Fusion (Glif) SystemMAX · Traditional | 05/19/2009SE |
| K090228 | Roc Lumbar Plating SystemMNH · Traditional | 04/29/2009SE |
| K090782 | Novel Alif Spinal Spacer SystemMAX · Special | 04/22/2009SE |
| K081730 | Novel Cervical Spinal Spacer SystemODP · Traditional | 09/19/2008SE |
| K081158 | Zodic Polyaxial Spinal Fixation SystemMNI · Special | 07/03/2008SE |
| K080699 | Novel Spinal Spacer SystemMQP · Traditional | 05/21/2008SE |
| K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemMNH · Traditional | 11/09/2007SE |
| K072081 | Zodiac Dynamo Semi-Rigid Spinal SystemKWP · Traditional | 10/24/2007SE |
| K071380 | Modification to Solanas Posterior Stabilization SystemNKB · Special | 08/20/2007SE |
| K063668 | Roc Lumbar SystemMNI · Traditional | 05/18/2007SE |
| K070681 | Next Generation Anterior Cervical Plating SystemKWQ · Traditional | 05/04/2007SE |
| K061321 | Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXMNH · Special | 07/07/2006SE |
| K052201 | Solanas Posterior Stabilization SystemKWP · Traditional | 11/10/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2793-2026 Class II | SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of… | 05/13/2026Open, Classified |
| Z-1343-2026 Class II | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF…Due a design issue where the navigated array connection geometry is incorrect. | 01/02/2026Open, Classified |
| Z-1342-2026 Class II | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF…Due a design issue where the navigated array connection geometry is incorrect. | 01/02/2026Open, Classified |
| Z-1065-2025 Class II | Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate…Complaints have been received regarding post-operative implant collapse. | 12/15/2024Open, Classified |
| Z-1182-2024 Class II | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 /…Due to reports of intraoperative graft bolt implantation breakages. | 01/26/2024Open, Classified |
| Z-2475-2023 Class II | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral…Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking… | 07/07/2023Open, Classified |
| Z-0196-2023 Class II | Disc Preparation instruments contained in the following products: CI-11050-08102515…Due to manufacturing instruments which included additional features and adequate consideration was not given… | 09/14/2022Open, Classified |
| Z-1827-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1826-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1825-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1824-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1823-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1822-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1821-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1820-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1819-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1818-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1817-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1816-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1815-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1814-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1813-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1812-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1811-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1810-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1809-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1808-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1807-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1806-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1805-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1804-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1803-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1802-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1801-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1800-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-1799-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | 04/26/2021Terminated |
| Z-2249-2017 Class II | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal…Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw… | 05/05/2017Terminated |
| Z-0592-2017 Class II | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The…Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw… | 10/05/2016Terminated |
| Z-1547-2015 Class II | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for…During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser… | 04/10/2015Terminated |
| Z-2092-2014 Class II | Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III…Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the… | 06/26/2014Terminated |
| Z-2086-2013 Class II | Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation…The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm… | 06/28/2013Terminated |
| Z-1421-2013 Class II | Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction…Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange… | 05/06/2013Terminated |
| Z-0168-2013 Class II | ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System…The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did… | 09/25/2012Terminated |
| Z-2273-2012 Class II | TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The…On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe… | 05/29/2012Terminated |
| Z-1676-2012 | SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal…Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for… | 03/19/2012Terminated |
| Z-0967-2013 Class II | ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY…The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact… | 07/06/2011Terminated |
| Z-0269-2013 Class II | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product…The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was… | 12/09/2010Terminated |
| Z-0932-2012 | Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior…These lots were not manufactured correctly in that the instrument does not have the durability required to… | 11/01/2010Terminated |
| Z-1746-2010 | Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec…The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the… | 08/25/2009Terminated |
| Z-0503-2010 | Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body… | 08/05/2009Terminated |
| Z-0502-2010 | Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body… | 08/05/2009Terminated |
| Z-0190-2010 | Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012…Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec… | 05/13/2009Terminated |
| Z-0498-2010 | ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior…The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar… | 01/28/2009Terminated |
| Z-0036-2010 | ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC…Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of… | 12/16/2008Terminated |
| Z-0491-2010 | Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a…Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side… | 11/03/2008Terminated |
| Z-0508-2009 | Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in…Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong… | 08/16/2007Terminated |
| Z-0507-2009 | Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the…Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong… | 08/16/2007Terminated |