The Recall Desk
HighFDA (Devices)·Z-1812-2021·Announced 2021-06-16

Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after 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 for a potential mechanical failure in an implanted surgical device. No injuries, deaths, or hospitalizations have been reported, making this a theoretical risk-of-harm scenario where injury has not yet been reported, which meets the High severity threshold.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0242), a medical device used in cervical spine surgery. The product includes 14 units distributed across 15 U.S. states.

The screw blocking mechanism on the anterior cervical plate may disassociate during surgery or unlock after surgery. This defect could affect the stability or function of the implant.

The affected product has codes 8663402R and 8609317R. Distribution was nationwide in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

Healthcare providers and patients who may have been affected should contact Alphatec Spine, Inc. or consult their healthcare provider if they have concerns about their implant. The FDA's recall number is Z-1812-2021.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
  • device-failure
  • implant-loosening

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)

  • 8663402R and 8609317R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category