Browse Device Recalls
45 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 45 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 45 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Alphatec Spine, Inc. |
| 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 | Alphatec Spine, Inc. |
| Dec 15, 2024 | Calibrate CCX Interbody System for spinal fusion procedures: Implants: ... | Complaints have been received regarding post-operative implant collapse. | Class II | Alphatec Spine, Inc. |
| 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 | Alphatec Spine, Inc. |
| 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 orientation, preventin... | Class II | Alphatec Spine, Inc. |
| Sep 14, 2022 | Disc Preparation instruments contained in the following products: CI-11050-0... | Due to manufacturing instruments which included additional features and adequate consideration wa... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| 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 to a trend in set sc... | Class II | Alphatec Spine, Inc. |
| 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 to a trend in set sc... | Class II | Alphatec Spine, Inc. |
| 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 Luxe Screw has been bot... | Class II | Alphatec Spine, Inc. |
| 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 received a report that ... | Class II | Alphatec Spine, Inc. |
| 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 Polyaxial Screws 7.5mm x 4... | Class II | Alphatec Spine, Inc. |
| May 6, 2013 | Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide... | Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing,... | Class II | Alphatec Spine, Inc. |
| 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 Illico MIS Fixation ... | Class II | Alphatec Spine, Inc. |
| 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 distal tip of the Tr... | Class II | Alphatec Spine, Inc. |
| 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, when they were in f... | Class II | Alphatec Spine, Inc. |
| 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 Standard Polyaxial Screw As... | Class II | Alphatec Spine, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.