The Recall Desk
HighFDA (Devices)·Z-1815-2021·Announced 2021-06-16

Anterior Cervical Plate System Recalled for Potential Screw Mechanism Failure

Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine 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 recall involving a mechanical failure risk in a surgical implant. No illnesses or injuries have been reported; the hazard is theoretical. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported.'

Plain-English summary

The Atec Insignia Anterior Cervical Plate System (model REF 136-0250, 2-level, 50mm) manufactured by Alphatec Spine, Inc. is being recalled. This device is used to stabilize the cervical spine during anterior cervical fusion surgery.

The recall was initiated due to a potential risk that the screw blocking mechanism could disassociate during surgery or after the procedure is complete, or unlock postoperatively. If this occurs, the implant may not properly stabilize the cervical spine.

The recalled device was distributed nationwide to healthcare facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

Patients and healthcare providers with this device should contact their physician to discuss the potential risk and determine appropriate next steps. Healthcare facilities should stop using remaining inventory of the affected product (code 8663405R) and contact Alphatec Spine for further guidance.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
  • implant-failure
  • screw-unlocking

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)

  • 8663405R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category