The Recall Desk
HighFDA (Devices)·Z-1801-2021·Announced 2021-06-16

Anterior cervical plate system screw mechanism may disassociate during or after surgery

Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.

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: Per the severity rubric, this qualifies as High (Score 3): it is a risk-of-harm product (spinal implant with potential mechanical failure) where no illnesses or injuries have been reported, and the hazard remains theoretical.

Plain-English summary

The Atec Insignia Anterior Cervical Plate System, manufactured by Alphatec Spine, Inc., is being recalled by the U.S. Food and Drug Administration due to a potential defect in the screw blocking mechanism.

The screw blocking mechanism on this anterior cervical plate system has the potential to disassociate intraoperatively (during surgery) or postoperatively (after surgery), or to unlock postoperatively. This defect could compromise the stability of the cervical spine implant.

The affected product is the Atec Insignia Anterior Cervical Plate System, 1-Level, 18 mm (REF 136-0118, UDI 01-00190376268446), code numbers 8609303R and 8800403, distributed nationwide to healthcare facilities in 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Seven units were distributed.

Patients who have received this implant should contact their healthcare provider to discuss their individual risk. Healthcare providers should assess whether affected devices have been used in patients and monitor those patients for any signs of implant failure.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Cervical Spine Plate
Hazard
Affected units
7

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)

  • 8609303R and 8800403

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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 →

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Same manufacturer · Alphatec Spine, Inc.

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Same hazard · implant failure

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