Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall involving a surgical spinal implant with a potential mechanical failure of the locking mechanism. The hazard could occur intraoperatively or postoperatively, posing risk to device stability. No injuries or hospitalizations have been reported in the source material.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (model REF 136-0119) due to a potential defect in the screw blocking mechanism. The mechanism may disassociate intraoperatively (during surgery) or postoperatively (after surgery), or unlock after surgery. This could compromise the stability and integrity of the surgical implant.
This recall affects 13 units that were distributed nationwide to medical facilities in the following states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
Patients who have received this implant should contact their surgeon to discuss the potential risk and determine whether any monitoring or intervention is necessary. Healthcare providers should immediately cease use of the affected product and consult the manufacturer regarding patient management recommendations.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- screw-disassociation
- mechanical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 8609304R
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03