The Recall Desk
HighFDA (Devices)·Z-1821-2021·Announced 2021-06-16

Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate

Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.

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 potential mechanical defect in a surgical implant where the screw blocking mechanism may disassociate or unlock postoperatively. No illnesses or injuries have been reported. The hazard represents a risk of implant failure and loss of spinal fusion support, meeting the criteria for High (score 3): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (model REF 136-0360). This surgical implant is used in anterior cervical spine fusion procedures. The affected product has code number 8609327R.

There is a potential defect in the screw blocking mechanism of the anterior cervical plate. The mechanism may disassociate (separate) during surgery or after surgery, and the screws may unlock postoperatively. This could result in loss of implant fixation and device failure.

The affected devices were distributed to healthcare facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant
Hazard
  • screw-failure
  • implant-failure

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)

  • 8609327R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category