The Recall Desk
HighFDA (Devices)·Z-1808-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate System Screw Mechanism May Disassociate

Alphatec Spine is recalling Insignia Anterior Cervical Plate Systems due to a potential defect where the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No patient injuries have been reported.

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 surgical implant with potential screw mechanism failure. Although no injuries have been reported and the hazard is characterized as potential, this represents a risk-of-harm situation in a critical spinal device, meeting Score 3 criteria.

Plain-English summary

Alphatec Spine, Inc. is recalling certain units of the Atec Insignia Anterior Cervical Plate System (REF 136-0234, Insignia ACP 2-Level, 34 mm, non-sterile). This device is a surgical implant used for anterior cervical spine stabilization. Affected product codes are 8609313R and 8800410.

Six units of the recalled product were distributed to medical facilities in the following U.S. states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

According to the FDA, there is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate during surgery (intraoperatively) or after surgery (postoperatively), or to unlock postoperatively. No patient injuries or illnesses have been reported.

Healthcare providers who have received this product should contact Alphatec Spine, Inc. for guidance on the appropriate steps to take. Patients who have received this implant should consult with their surgeon to discuss the recall and any potential risks.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant - Spine
Hazard
  • screw-failure
  • device-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)

  • 8609313R and 8800410

Distribution

Distributed nationwide across the United States.

Related recalls

Same category