Alphatec Spine, Inc.

Complete recall history across all FDA and CPSC categories — 45 total recalls

Alphatec Spine, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (45)

FDA medical device enforcement actions by Alphatec Spine, Inc.

Date Product Reason Class
Jan 2, 2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... Due a design issue where the navigated array connection geometry is incorrect. Class II
Jan 2, 2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... Due a design issue where the navigated array connection geometry is incorrect. Class II
Dec 15, 2024 Calibrate CCX Interbody System for spinal fusion procedures: Implants: ... Complaints have been received regarding post-operative implant collapse. Class II
Jan 26, 2024 IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-8... Due to reports of intraoperative graft bolt implantation breakages. Class II
Jul 7, 2023 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine... Awl instrument adjustable drill button assembly assembled in the incorrect or... Class II
Sep 14, 2022 Disc Preparation instruments contained in the following products: CI-11050-0... Due to manufacturing instruments which included additional features and adequ... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervic... Class II
May 5, 2017 Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage:... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due ... Class II
Oct 5, 2016 Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Us... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due ... Class II
Apr 10, 2015 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine S... During a field audit it was discovered by an employee that a 16mm Trestle Lux... Class II
Jun 26, 2014 Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the S... Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they rec... Class II
Jun 28, 2013 Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior F... The firm initiated this recall of certain lots of Illico Ti Cannulated Polyax... Class II
May 6, 2013 Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide... Alphatec Spine initiated this medical device recall for the following reason:... Class II
Sep 25, 2012 ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation S... The firm initiated the recall because the stainless steel guide-wire of the ... Class II
May 29, 2012 TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102... On May 9th 2012 Alphatec Spine received a complaint which reported that the d... Class II
Jul 6, 2011 ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.... The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm,... Class II
Dec 9, 2010 TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subse... The recall was initiated because Alphatec Spine confirmed that the TI Standar... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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