Brand recall history

Alphatec Spine recalls

Every FDA recall record we found for Alphatec Spine, newest first. Updated Oct. 11, 2026.

26 recalls since 2008. The most recent was on July 29, 2026.

Last 12 months: 2
Most recent: 2026-07
Most serious (FDA Class I): 0
Last 30 days: 0

Recalls by year

2012–2026

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Class I (FDA, most serious)Other recalls

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Recent recalls

2 of 26

July 29, 2026Class IIFDA · Medical device

SafeOp Patient Interface…

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…

Filed by: Alphatec Spine, Inc.

Feb. 18, 2026Class IIFDA · Medical device

ATEC Lateral Navigation Disc Prep Instruments LIF NAV… and 1 more product

Due a design issue where the navigated array connection geometry is incorrect.

Filed by: Alphatec Spine, Inc.

More recalls

Feb. 5, 2025Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O… Class IIComplaints have been received regarding post-operative implant collapse.
March 6, 2024IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft… Class IIDue to reports of intraoperative graft bolt implantation breakages.
Sept. 6, 2023Lif Amp… Class IIAwl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the…
Nov. 16, 2022Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial… Class IIDue to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
June 16, 2021Atec Insignia Anterior Cervical Plate System… and 28 more products Class IIThere is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or…
June 14, 2017Arsenal Spinal Fixation System… Class IIAlphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
Nov. 23, 2016Arsenal Spinal Fixation System… Class IIAlphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
May 6, 20154.0mm Variable Angle… Class IIDuring a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe…
July 30, 2014Solanas 2.1mm FIXED DEPTH DRILL… Class IIAlphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid…
Sept. 4, 2013Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm… Class IIThe firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole…
June 5, 2013Leucadia Autolok" Polyaxial Pedicle Screw System… Class IIAlphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set…
March 27, 2013ILLICO Straight CP TI Rod… Class IIThe rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Nov. 14, 2012TI Standard Polyaxial Screw Assembly 6.5MM x 55MM… Class IIThe recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of…
Nov. 7, 2012ILLlCO¿ MIS Posterior Fixation System… Class IIThe firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of…
Sept. 5, 2012TRESTLE LUXE¿ Anterior Cervical Plating System… Class IIOn May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721)…
May 29, 2012SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System… Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been…
Jan. 31, 2012Solanas Posterior Stabilization System Part Number: 63920… These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service…
June 2, 2010Trestle Anterior Cervical Plate 1-level assembly… The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part…
Dec. 14, 2009Alphatec Spine Solanas Titanium Pedicle Screw… and 1 more product Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees…
Dec. 11, 2009ILLICO Posterior Thoracolumbar Access Retractor… The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one…
Dec. 7, 2009Zodiac Polyaxial Spinal Fixation System… Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are…
Nov. 12, 2009Alphatec Spine… Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to…
Oct. 8, 2009ROC Lumbar bolt caddy… Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves…
Dec. 31, 2008Novel PEEK VBR XS 16-22 MM… and 1 more product Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were…

How we match: a recall is listed here when the agency names Alphatec Spine as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.

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