The Recall Desk
HighFDA (Devices)·Z-1806-2021·Announced 2021-06-16

Anterior Cervical Plate System Screw Lock Mechanism May Fail Intraoperatively or Postoperatively

The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.

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 of a surgical implant with a concrete failure mode affecting a critical anatomical region. Although no adverse events or injuries have been reported, the potential for device lock failure during or after cervical spine surgery constitutes a risk-of-harm scenario, which meets the criteria for severity score 3.

Plain-English summary

The Alphatec Insignia Anterior Cervical Plate System, model REF 136-0124, is subject to recall. This surgical implant is used in anterior cervical spine fusion procedures. Eight units of the device 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.

Alphatec Spine, Inc., initiated the recall due to a potential failure of the screw blocking mechanism. The mechanism may disassociate during surgery (intraoperatively) or unlock after surgery (postoperatively).

Detailed guidance regarding this recall, including recommended actions for affected patients and healthcare providers, should be obtained from the official FDA recall notice or Alphatec Spine directly.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Cervical Spine Implant
Hazard
Affected units
8

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)

  • 8609309R

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 disassociation

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