Recall archive
17 recalls · page 1 of 1
Reported Jul 29, 2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG)…
FDA (openFDA device enforcement)
Reported Feb 18, 2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — Due a design issue where the navigated array connection geometry is incorrect.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — Complaints have been received regarding post-operative implant collapse.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — Due to reports of intraoperative graft bolt implantation breakages.
FDA (openFDA device enforcement)
Reported Sep 6, 2023
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product · Product details — Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the…
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or…
28 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2017
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Reason for recall — Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
FDA (openFDA device enforcement)
Reported Nov 23, 2016
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Reason for recall — Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
FDA (openFDA device enforcement)
Reported May 6, 2015
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product · Product details — During 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…
FDA (openFDA device enforcement)
Reported Jul 30, 2014
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product details · Reason for recall — Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid…
FDA (openFDA device enforcement)
Reported Sep 4, 2013
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand — The 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…
FDA (openFDA device enforcement)
Reported Jun 5, 2013
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Reason for recall — Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set…
FDA (openFDA device enforcement)
Reported Mar 27, 2013
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product · Product details — The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
FDA (openFDA device enforcement)
Reported Nov 14, 2012
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product details · Reason for recall — The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of…
FDA (openFDA device enforcement)
Reported Nov 7, 2012
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product details — The 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…
FDA (openFDA device enforcement)
Reported Sep 5, 2012
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alphatec Spine, Inc.
Matched: Brand · Product details · Reason for recall — On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721),…
FDA (openFDA device enforcement)
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