Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure
Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.
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: FDA Class II recall for a surgical implant with a potential device malfunction (screw blocking mechanism disassociation/unlock). No illnesses or injuries reported to date. Per the rubric, this is a risk-of-harm medical device where injury has not yet been reported, placing it in the High category.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0244, codes 8663403R and 8609318R) due to a potential defect in the screw blocking mechanism. The mechanism may disassociate during surgery or after implantation, or unlock after surgery.
Three units were distributed nationwide to facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
No injuries or adverse events have been reported. Patients and healthcare providers should be aware of this potential risk with the affected device.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 3
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)
- 8663403R & 8609318R
Distribution
Part of a larger recall action
This product is one of 29 recalled by Alphatec Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 29 products in this recall →Related recalls
Same manufacturer · Alphatec Spine, Inc.
See all →- HighSafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue
FDA (Devices) · 2026-07-29
- ModerateSpinal navigation instruments recalled over incorrect array connection geometry
FDA (Devices) · 2026-02-18
- ModerateNavigation osteotomes recalled over incorrect array connection geometry
FDA (Devices) · 2026-02-18
- HighAlphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse
FDA (Devices) · 2025-02-05
- HighIdentiTi ALIF surgical graft bolts recalled due to intraoperative breakage
FDA (Devices) · 2024-03-06
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12