The Recall Desk
HighFDA (Devices)·Z-1825-2021·Announced 2021-06-16

Cervical Plate System screw locking mechanism may fail during or after surgery

Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.

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: Class II FDA medical device recall where no injuries have been reported and the hazard is characterized as potential. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity rating.

Plain-English summary

The Atec Insignia Anterior Cervical Plate System (REF 136-0474, 4-level, 74 mm) manufactured by Alphatec Spine, Inc., is being recalled due to a potential defect in the screw blocking mechanism. The mechanism may disassociate during or after surgery, or may unlock after surgery.

The recall affects 5 units distributed across the United States, including Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. The specific lot code is 8609333R.

Patients who have received this implant should contact their surgeon or healthcare provider immediately to discuss potential risks and appropriate follow-up or monitoring. Healthcare providers should verify their inventory for this specific implant and assess patient status if it was used.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spine Surgery Implant
Hazard
  • locking-failure
  • implant-malfunction

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)

  • 8609333R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category