The Recall Desk
HighFDA (Devices)·Z-1820-2021·Announced 2021-06-16

Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall

Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine 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 risk-of-harm medical device product (surgical implant for cervical spine) where potential mechanical failure could compromise spinal stability. Although classified as FDA Class II, no hospitalizations or injuries are reported in the source; the hazard is characterized as potential rather than confirmed.

Plain-English summary

The Atec Insignia Anterior Cervical Plate System (REF 136-0358, 3-Level, 58 mm, non-sterile, UDI 01-00190376268606), manufactured by Alphatec Spine, Inc., is being recalled. The recalled product is identified by code 8609326R.

There is a potential for the screw blocking mechanism on this anterior cervical plate system to disassociate during surgery (intraoperatively) or unlock after surgery (postoperatively). This mechanism failure could compromise the mechanical stability of the implanted plate.

Three units were distributed nationwide across 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant / Cervical Plate
Hazard
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)

  • 8609326R

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 →

Related recalls

Same manufacturer · Alphatec Spine, Inc.

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Same hazard · screw mechanism failure

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