The Recall Desk
HighFDA (Devices)·Z-1811-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate System screw locking mechanism failure

Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal 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 an FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard—screw locking mechanism failure in a surgical implant—represents a risk of harm to patients. Per the severity rubric, risk-of-harm products with no reported injury score at High (3).

Plain-English summary

Alphatec Spine, Inc. is recalling the Insignia Anterior Cervical Plate System (REF 136-0240), a surgical implant used in anterior cervical spinal fusion procedures. The device is a metal plate system with screw fixation. Approximately 26 units were distributed nationwide.

The screw blocking mechanism on the anterior cervical plate may disassociate or unlock either during the surgical procedure or at any time after implantation. Healthcare providers and patients should be aware of this potential defect.

Patients who have received this implant should contact their healthcare provider regarding this recall. Healthcare providers should review their records for affected patients and determine appropriate follow-up care.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
26

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 (2)

  • 8663401R
  • 8609316R

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 · mechanism failure

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