The Recall Desk
HighFDA (Devices)·Z-1819-2021·Announced 2021-06-16

Anterior Cervical Plate System Recalled for Screw Locking Failure

Alphatec Spine is recalling its Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism during or after surgery that could compromise implant stability.

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 of a surgical implant with potential for mechanical failure that could compromise cervical fusion stability. The hazard is described as a potential risk with no reported illnesses or injuries, meeting the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (Insignia ACP, 3-Level, 56 mm) because the screw blocking mechanism may disassociate during or after surgery, or unlock after surgery. This defect could compromise the stability of the cervical fusion.

The recalled product is REF 136-0356 (Code 8609325R), with five units distributed across 14 U.S. states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

Healthcare providers should counsel patients who received this implant about the potential defect and monitor them for any signs of implant instability or failure. Patients should contact their healthcare provider immediately if they experience neck pain, instability, or neurological symptoms.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • screw-failure
  • implant-instability

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)

  • 8609325R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category