The Recall Desk
HighFDA (Devices)·Z-1816-2021·Announced 2021-06-16

Alphatec Insignia Cervical Plate System Screw Locking Mechanism May Disassociate or Unlock

Alphatec Spine is recalling the 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 Class II medical device recall involves a risk-of-harm product (cervical spinal implant) where the defective mechanism could compromise implant stability. No illnesses or injuries have been reported in the source material, placing this in the 'High' category per the rubric for risk-of-harm products without yet-reported injury.

Plain-English summary

The Insignia Anterior Cervical Plate System, manufactured by Alphatec Spine, Inc., is designed for anterior cervical spine fusion surgery. The system includes a screw blocking mechanism intended to secure the plate in place during and after the surgical procedure.

The FDA has classified this recall as Class II due to a potential defect in the screw blocking mechanism. The mechanism may disassociate during surgery or may unlock after the procedure has been completed. If the mechanism fails to remain secure, it could compromise the stability of the spinal implant.

The affected product (REF 136-0350, UDI 00190376268569, with lot code 8609322R) was distributed nationwide across the following states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Healthcare providers who have these systems in stock or have implanted them in patients should contact Alphatec Spine, Inc., immediately for guidance on affected units and potential remedial measures. Patients who have received this implant should consult with their healthcare provider about whether follow-up evaluation is appropriate.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
  • implant-failure
  • mechanism-disassociation

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)

  • 8609322R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category