The Recall Desk
HighFDA (Devices)·Z-1805-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate Screw Mechanism Failure Recall

Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during surgery or unlock afterward. Eight units were distributed across 15 states.

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 medical device. The potential failure of the screw blocking mechanism in a spinal implant poses serious risk of patient harm. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0122) due to a potential failure of the screw blocking mechanism. This device is used in anterior cervical spine surgery to stabilize the cervical vertebrae.

The screw blocking mechanism may disassociate intraoperatively or postoperatively, or may unlock after the procedure is complete. If the mechanism fails, the spinal stabilization provided by the plate could be compromised, potentially affecting the integrity of the surgical reconstruction.

This recall affects 8 units with code 8609307R. The affected devices were distributed nationwide in the following states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

Patients who have received this implant should consult with their surgeon regarding this recall. Healthcare providers should contact Alphatec Spine, Inc. for additional information and guidance.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant / Spinal Hardware
Hazard
  • screw-loosening
  • 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)

  • 8609307R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category