The Recall Desk
HighFDA (Devices)·Z-1803-2021·Announced 2021-06-16

Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock

Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which 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: FDA Class II recall involving a potential mechanical failure of a critical spinal implant with no reported illnesses or injuries. The hazard is theoretical, placing this at the maximum severity for recalls with no actual adverse events, consistent with risk-of-harm products.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0120, 1-Level, 20 mm) used in anterior cervical spine fusion surgery. The system's screw blocking mechanism has the potential to disassociate or unlock during or after surgery, which could compromise the stability of the surgical repair.

Approximately 10 units were distributed to medical facilities in 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

No illnesses or injuries have been reported in connection with this defect. Patients and healthcare providers should be aware of this potential mechanical failure and contact Alphatec Spine with any questions or concerns regarding this recall.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Orthopedic / Cervical Spine
Hazard
Affected units
10

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)

  • 8609305R

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 · implant failure

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